Actively controllable stent, stent graft, heart valve and method of controlling same

ABSTRACT

A method for implanting a stent includes contracting a self-expanding/forcibly-expanding stent of a shape-memory material set to a given shape to a reduced implantation size with a delivery system having drive wires. The stent has a selectively adjustable assembly with adjustable elements operatively connected to the drive wires such that, when the adjustable elements are adjusted by the drive wires, a configuration change in at least a portion of the self-expanding stent occurs. The contracted stent is inserted into a native annulus in which the stent is to be implanted. The drive wires are rotated with the delivery system to forcibly expand the stent into the native annulus. While rotating the drive wires, a torque applied to the drive wires is determined with the delivery system. Rotation of the drive wires is stopped based upon a value of the determined torque.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 61/824,264, filed May 16, 2013, and is acontinuation-in-part of U.S. patent application Ser. No. 13/772,203,filed Feb. 20, 2013, and Ser. No. 13/656,717, filed Oct. 21, 2012, nowU.S. Pat. No. 9,566,178. U.S. patent application Ser. No. 13/772,203claims the benefit of U.S. Provisional Patent Application Nos.61/739,711, filed Dec. 19, 2012, 61/717,037, filed Oct. 22, 2012,61/682,558, filed Aug. 13, 2012, and 61/601,961, filed Feb. 22, 2012.U.S. patent application Ser. No. 13/656,717 claims the benefit of U.S.Provisional Patent Application Nos. 61/682,558, filed Aug. 13, 2012,61/601,961, filed Feb. 22, 2012, 61/591,753, filed Jan. 27, 2012,61/585,937, filed Jan. 12, 2012, and 61/550,004, filed Oct. 21, 2011.The prior applications are incorporated by reference herein in theirentireties.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

Not Applicable

FIELD OF THE INVENTION

The present invention lies in the field of stents, stent grafts, heartvalves (including aortic, pulmonary, mitral and tricuspid), and methodsand systems for controlling and implanting stents, stent grafts andheart valves.

BACKGROUND OF THE INVENTION

Medical and surgical implants are placed often in anatomic spaces whereit is desirable for the implant to conform to the unique anatomy of thetargeted anatomic space and secure a seal therein, preferably withoutdisturbing or distorting the unique anatomy of that targeted anatomicspace.

While the lumens of most hollow anatomic spaces are ideally circular, infact, the cross-sectional configurations of most anatomic spaces are, atbest, ovoid, and may be highly irregular. Such lumenal irregularity maybe due to anatomic variations and/or to pathologic conditions that maychange the shape and topography of the lumen and its associated anatomicwall. Examples of anatomic spaces where such implants may be deployedinclude, but are not limited to, blood vessels, the heart, othervascular structures, and vascular defects (such as thoracic andabdominal aortic aneurysms).

For a patient to be a candidate for existing endograft methods andtechnologies, to permit an adequate seal, a proximal neck of, ideally,at least 12 mm of normal aorta must exist downstream of the leftsubclavian artery for thoracic aortic aneurysms or between the origin ofthe most inferior renal artery and the origin of the aneurysm in thecase of abdominal aneurysms. Similarly, ideally, at least 12 mm ofnormal vessel must exist distal to the distal extent of the aneurysm foran adequate seal to be achieved. The treatment of Aortic Stenosisthrough Transcather Aortic Valve Replacement (TAVR) is becoming morecommon. The limitations of current TAVR techniques do not allow forrepositioning of the implant once it has been deployed in place.Further, the final expanded diameter of the current devices is fixedmaking pre-sizing a critical and difficult step.

Migration of existing endografts has also been a significant clinicalproblem, potentially causing leakage and profusion of aneurysms and/orcompromising necessary vascular supplies to arteries such as thecoronary, carotid, subclavian, renal, or internal iliac vessels. Thisproblem only has been addressed partially by some existing endograftdesigns, in which barbs or hooks have been incorporated to help retainthe endograft at its intended site. However, most existing endograftdesigns are solely dependent on radial force applied by varying lengthof stent material to secure a seal against the recipient vessel walls.

Because of the limitations imposed by existing vascular endograftdevices and endovascular techniques, a significant number of abdominaland thoracic aneurysms repaired in the U.S. are still managed thoughopen vascular surgery, instead of the lower morbidity of theendovascular approach.

Pre-sizing is required currently in all prior art endografts. Suchpre-sizing based on CAT-scan measurements is a significant problem. Thisleads, many times, to mis-sized grafts. In such situations, more graftsegments are required to be placed, can require emergency open surgery,and can lead to an unstable seal and/or migration. Currently thereexists no endograft that can be fully repositioned after deployment.

Thus, a need exists to overcome the problems with the prior art systems,designs, and processes as discussed above.

SUMMARY OF THE INVENTION

The invention provides surgical implant devices and methods for theirmanufacture and use that overcome the hereinafore-mentioneddisadvantages of the heretofore-known devices and methods of thisgeneral type and that provide such features with improvements thatincrease the ability of such an implant to be precisely positioned andsealed, with better in situ accommodation to the local anatomy of thetargeted anatomic site. The invention provides an adjustment tool thatcan remotely actuate an adjustment member(s) that causes a configurationchange of a portion(s) of an implant, which configuration changeincludes but is not limited to diameter, perimeter, shape, and/orgeometry or a combination of these, to create a seal and provideretention of an implant to a specific area of a target vessel orstructure even when the cross-sectional configuration of the anatomicspace is non-circular, ovoid, or irregular.

The invention provides an actively controllable stent, stent graft,stent graft assembly, heart valve, and heart valve assembly, and methodsand systems for controlling and implanting such devices that overcomethe hereinafore-mentioned disadvantages of the heretofore-known devicesand methods of this general type and that provide such features withcontrol both in opening and closing and in any combination thereof evenduring a surgical procedure or after completion of a surgical procedure.

One exemplary aspect of the present invention is directed towards noveldesigns for endovascular implant grafts, and methods for their use forthe treatment of aneurysms (e.g., aortic) and other structural vasculardefects. An endograft system for placement in an anatomic structure orblood vessel is disclosed in which an endograft implant comprises, forexample, a non-elastic tubular implant body with at least anaccommodating proximal end. Accommodating, as used herein, is theability to vary a configuration in one or more ways, which can includeelasticity, expansion, contraction, and changes in geometry. Both oreither of the proximal and distal ends in an implant according to thepresent invention further comprise one or more circumferentialexpandable sealable collars and one or more expandable sealing devices,capable of being expanded upon deployment to achieve the desired sealbetween the collar and the vessel's inner wall. Exemplary embodiments ofsuch devices can be found in co-pending U.S. patent application Ser. No.11/888,009, filed Jul. 31, 2007, and Ser. No. 12/822,291, filed Jun. 24,2010, which applications have been incorporated herein in theirentireties. Further embodiments of endovascular implants and deliverysystems and methods according to the present invention may be providedwith retractable retention tines or other retention devices allowing animplant to be repositioned before final deployment. In otherembodiments, the implant can be repositioned after final deployment. Anendograft system according to the present invention further comprises adelivery catheter with an operable tubular sheath capable of housing afolded or compressed endograft implant prior to deployment and capableof retracting or otherwise opening in at least its proximal end to allowimplant deployment. The sheath is sized and configured to allow itsplacement via a peripheral arteriotomy site, and is of appropriatelength to allow its advancement into, for example, the aortic valveannulus, ascending aorta, aortic arch, and thoracic or abdominal aorta,as required for a specific application. Sheath movement is provided in anovel manner by manual actuation and/or automatic actuation.

While some post-implantation remodeling of the aortic neck proximal toan endovascular graft (endograft) has been reported, existing endografttechnology does not allow for the management of this condition withoutplacement of an additional endograft sleeve to cover the remodeledsegment. Exemplary prostheses of the present invention as describedherein allow for better accommodation by the implant of the localanatomy, using an actively controlled expansion device for the sealinginterface between the prosthesis collar and the recipient vessel's innerwall. Furthermore, exemplary prostheses of the present invention asdisclosed herein are provided with a controllably releasable disconnectmechanism that allows remote removal of an adjustment tool and lockingof the retained sealable mechanism after satisfactory positioning andsealing of the endograft. In some exemplary embodiments according to thepresent invention, the controllably releasable disconnect mechanism maybe provided in a manner that allows post-implantation re-docking of anadjustment member to permit post-implantation repositioning and/orresealing of a prostheses subsequent to its initial deployment.

Certain aspects of the present invention are directed towards noveldesigns for sealable endovascular implant grafts and endovascularimplants, and methods for their use for the treatment of aorticaneurysms and other structural vascular defects and/or for heart valvereplacements. Various embodiments as contemplated within the presentinvention may include any combination of exemplary elements as disclosedherein or in the co-pending patent applications referenced above.

In an exemplary embodiment according to the present invention, asealable vascular endograft system for placement in a vascular defect isprovided, comprising an elongated main implant delivery catheter with anexternal end and an internal end for placement in a blood vessel withinternal walls. In such an exemplary embodiment, the main implantdelivery catheter further comprises a main implant delivery cathetersheath that may be openable or removable at the internal end and a mainimplant delivery catheter lumen containing within a compressed or foldedendovascular implant. Further, an endovascular implant comprises anon-elastic tubular implant body with an accommodating proximal endterminating in a proximal sealable circumferential collar that may beexpanded by the operator to achieve a fluid-tight seal between theproximal sealable circumferential collar and the internal walls of theblood vessel proximal to the vascular defect. Moreover, an endovascularimplant may further comprise a non-elastic tubular implant body with anaccommodating distal end terminating in a distal sealablecircumferential collar controlled by a distal variable sealing device,which may be expanded by the operator to achieve a fluid-tight sealbetween the distal sealable circumferential collar and the internalwalls of the blood vessel distal to the vascular defect.

In a further exemplary embodiment according to the present invention, animplant interface is provided for a sealable attachment of an implant toa wall within the lumen of a blood vessel or other anatomic conduit.

In a yet further exemplary embodiment according to the presentinvention, an implant gasket interface is provided for a sealableattachment of an implant to a wall within the lumen of a blood vessel orother anatomic conduit, wherein the sealable attachment provides forauto-adjustment of the seal while maintaining wall attachment toaccommodate post-implantation wall remodeling.

Still other exemplary embodiments of endografts and endograft deliverysystems according to the present invention serve as universal endograftcuffs, being first placed to offer their advantageous anatomicaccommodation capabilities, and then serving as a recipient vessel forother endografts, including conventional endografts.

Furthermore, exemplary embodiments of endografts and endograft deliverysystems according to the present invention may be provided with amechanism to permit transfer of torque or other energy from a remoteoperator to an adjustment member comprising a sealable, adjustablecircumferential assembly controlled by an adjustment tool, which may bedetachable therefrom and may further cause the assembly to lock upondetachment of the tool. In some exemplary embodiments of the presentinvention, the variable sealing device may be provided with a re-dockingelement that may be recaptured by subsequent operator interaction,allowing redocking and repositioning and/or resealing of the endograftat a time after its initial deployment.

Moreover, the various exemplary embodiments of the present invention asdisclosed herein may constitute complete endograft systems, or they maybe used as components of a universal endograft system as disclosed inco-pending patent applications that may allow the benefits of thepresent invention to be combined with the ability to receive otherendografts.

Additionally, the present invention encompasses sealable devices thatmay be used in other medical devices such as adjustable vascularcannulas or other medical or surgical devices or implants, such as heartvalves.

With the foregoing and other objects in view, there is provided, inaccordance with the invention, a method for implanting a stent includescontracting a self-expanding/forcibly-expanding stent of a shape-memorymaterial set to a given shape to a reduced implantation size with adelivery system having drive wires. The stent has a selectivelyadjustable assembly with adjustable elements operatively connected tothe drive wires such that, when the adjustable elements are adjusted bythe drive wires, a configuration change in at least a portion of theself-expanding stent occurs. The contracted stent is inserted into anative annulus in which the stent is to be implanted. The drive wiresare rotated with the delivery system to forcibly expand the stent intothe native annulus. While rotating the drive wires, a torque applied tothe drive wires is determined with the delivery system. Rotation of thedrive wires is stopped based upon a value of the determined torque.

With the objects of the invention in view, there is also provided amethod for implanting a stent includes contracting a stent to a reducedimplantation size with a delivery system having drive wires. The stenthas a selectively adjustable assembly with adjustable elementsoperatively connected to the drive wires such that, when the adjustableelements are adjusted by the drive wires, a configuration change in atleast a portion of the stent occurs. The contracted stent is insertedinto a native annulus in which the stent is to be implanted. The drivewires are rotated with the delivery system to forcibly expand the stentinto the native annulus. While rotating the drive wires, a torqueapplied to the drive wires is determined with the delivery system.Rotation of the drive wires is stopped based upon a value of thedetermined torque.

With the objects of the invention in view, there is also provided amethod for implanting a stent includes contracting a stent to a reducedimplantation size with a delivery system having drive wires. The stenthas a selectively adjustable assembly with adjustable elementsoperatively connected to the drive wires such that, when the adjustableelements are adjusted by the drive wires, a configuration change in atleast a portion of the stent occurs. The contracted stent is insertedinto a native annulus in which the stent is to be implanted. The drivewires are move with the delivery system to forcibly expand the stentinto the native annulus. While moving the drive wires, a torque appliedto the drive wires is determined with the delivery system. Movement ofthe drive wires is stopped based upon a value of the determined torque.

In accordance with another mode of the invention, a user is providedwith a dynamic value of the torque and permitting the user to change theexpansion and contraction of the stent.

In accordance with a further mode of the invention, the stent isdisconnected from the delivery system to implant the stent in the nativeannulus.

In accordance with an added mode of the invention, the delivery systemhas at least one drive wire motor connected to the drive wires forrotating the drive wires and the stopping step is carried out bymeasuring a current required to drive the at least one drive wire motorand stopping the at least one drive wire motor and thereby the rotationof the drive wires based upon a value of the current.

In accordance with an additional mode of the invention, an outwardradial force imposed by the expanding stent lattice on the nativeannulus is calculated with the value of the current and the at least onedrive wire motor and thereby the rotation of the drive wires is stoppedbased upon a value of the calculated outward radial force.

In accordance with a concomitant mode of the invention, the deliverysystem has at least one drive wire motor connected to the drive wiresfor rotating the drive wires and the stopping step is carried out bydetermining an outward radial force imposed by the expanding stentlattice based upon a current required to drive the at least one drivewire motor and stopping the at least one drive wire motor and therebythe rotation of the drive wires based upon a value of the a value of thecalculated outward radial force.

Although the invention is illustrated and described herein as embodiedin an actively controllable stent, stent graft, stent graft assembly,heart valve, and heart valve assembly, and methods and systems forcontrolling and implanting such devices, it is, nevertheless, notintended to be limited to the details shown because variousmodifications and structural changes may be made therein withoutdeparting from the spirit of the invention and within the scope andrange of equivalents of the claims. Additionally, well-known elements ofexemplary embodiments of the invention will not be described in detailor will be omitted so as not to obscure the relevant details of theinvention.

Additional advantages and other features characteristic of the presentinvention will be set forth in the detailed description that follows andmay be apparent from the detailed description or may be learned bypractice of exemplary embodiments of the invention. Still otheradvantages of the invention may be realized by any of theinstrumentalities, methods, or combinations particularly pointed out inthe claims.

Other features that are considered as characteristic for the inventionare set forth in the appended claims. As required, detailed embodimentsof the present invention are disclosed herein; however, it is to beunderstood that the disclosed embodiments are merely exemplary of theinvention, which can be embodied in various forms. Therefore, specificstructural and functional details disclosed herein are not to beinterpreted as limiting, but merely as a basis for the claims and as arepresentative basis for teaching one of ordinary skill in the art tovariously employ the present invention in virtually any appropriatelydetailed structure. Further, the terms and phrases used herein are notintended to be limiting; but rather, to provide an understandabledescription of the invention. While the specification concludes withclaims defining the features of the invention that are regarded asnovel, it is believed that the invention will be better understood froma consideration of the following description in conjunction with thedrawing figures, in which like reference numerals are carried forward.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying figures, where like reference numerals refer toidentical or functionally similar elements throughout the separateviews, which are not true to scale, and which, together with thedetailed description below, are incorporated in and form part of thespecification, serve to illustrate further various embodiments and toexplain various principles and advantages all in accordance with thepresent invention. Advantages of embodiments of the present inventionwill be apparent from the following detailed description of theexemplary embodiments thereof, which description should be considered inconjunction with the accompanying drawings in which:

FIG. 1 is a fragmentary, partially longitudinally cross-sectional, sideelevational view of an exemplary embodiment of an actively controllablestent/stent graft deployment system of the present invention in anon-deployed state with a front half of the outer catheter removed;

FIG. 2 is a fragmentary, side elevational view of an enlarged distalportion of the stent deployment system of FIG. 1;

FIG. 3 is a fragmentary, perspective view of the stent deployment systemof FIG. 1 from above the distal end;

FIG. 4 is a fragmentary, perspective view of the stent deployment systemof FIG. 1 from above the distal end with the system in a partiallydeployed state;

FIG. 5 is a fragmentary, side elevational view of the stent deploymentsystem of FIG. 2 in a partially deployed state;

FIG. 6 is a is a top plan view of a drive portion of the stentdeployment system of FIG. 2;

FIG. 7 is a fragmentary, longitudinally cross-sectional view of a rearhalf of the stent deployment system of FIG. 6;

FIG. 8 is a fragmentary, perspective view of the stent deployment systemof FIG. 6;

FIG. 9 is a fragmentary, perspective view of the stent deployment systemof FIG. 1 from above the distal end with the system in an expanded stateand with the assembly-fixed needles in an extended state;

FIG. 10 is a fragmentary, longitudinal cross-sectional view of the stentdeployment system of FIG. 9 showing the rear half in a partiallyexpanded state of the stent lattice;

FIG. 11 is a fragmentary, longitudinal cross-sectional view of the stentdeployment system of FIG. 10 showing the front half in a furtherexpanded state;

FIG. 12 is a fragmentary, longitudinal cross-sectional view of the stentdeployment system of FIG. 11 with a deployment control assembly in apartially disengaged state;

FIG. 13 is a fragmentary, longitudinally cross-sectional view of thestent deployment system of FIG. 12 with the deployment control assemblyin a disengaged state;

FIG. 14 is a fragmentary, longitudinally cross-sectional view of anenlarged portion of the stent deployment system of FIG. 12 in thepartially disengaged state;

FIG. 15 is a fragmentary, longitudinally cross-sectional view of anenlarged portion of the stent deployment system of FIG. 13 in adisengaged state;

FIG. 16 is a fragmentary, partially cross-sectional, side elevationalview of the stent deployment system of FIG. 9 rotated about alongitudinal axis, with the deployment control assembly in thedisengaged state, and showing a cross-section of a portion of thedeployment control assembly;

FIG. 17 is a fragmentary, longitudinally cross-sectional view of thestent deployment system of FIG. 16 showing a cross-section of a driveportion of a stent assembly with a fixed needle;

FIG. 18 is a fragmentary, perspective view of the stent deploymentsystem of FIG. 16;

FIG. 19 is a fragmentary, perspective view of an enlarged portion of thestent deployment system of FIG. 18;

FIG. 20 is a fragmentary, perspective view of the stent deploymentsystem of FIG. 18 with a diagrammatic illustration of paths of travel ofstrut crossing points as the stent is moved between its expanded andcontracted states;

FIG. 21 is a fragmentary, side elevational view from an outer side of analternative exemplary embodiment of a jack assembly according to theinvention in a stent-contracted state with a drive sub-assembly in aconnected state and with a needle sub-assembly in a retracted state;

FIG. 22 is a fragmentary, cross-sectional view of the jack assembly ofFIG. 21;

FIG. 23 is a fragmentary, cross-sectional view of the jack assembly ofFIG. 21 in a partially stent-expanded state;

FIG. 24 is a fragmentary, cross-sectional view of the jack assembly ofFIG. 23 with a needle pusher in a partially actuated state beforeextension of the needle;

FIG. 25 is a fragmentary, cross-sectional view of the jack assembly ofFIG. 24 with the needle pusher in another partially actuated state withthe needle pusher in another partially actuated state with an extensionof the needle;

FIG. 26 is a fragmentary, cross-sectional view of the jack assembly ofFIG. 25 with the drive sub-assembly in a partially disconnected statewithout retraction of the needle pusher;

FIG. 27 is a fragmentary, cross-sectional view of the jack assembly ofFIG. 26 with the drive sub-assembly in a further partially disconnectedstate with partial retraction of the needle pusher;

FIG. 28 is a fragmentary, cross-sectional view of the jack assembly ofFIG. 27 with the drive sub-assembly in a still a further partiallydisconnected state with further retraction of the needle pusher;

FIG. 29 is a fragmentary, cross-sectional view of the jack assembly ofFIG. 23 with the drive sub-assembly and the needle pusher in adisconnected state;

FIG. 30 is a fragmentary, cross-sectional view of another alternativeexemplary embodiment of a jack assembly according to the invention in astent-contracted state with a drive sub-assembly in a connected stateand with a needle sub-assembly in a retracted state;

FIG. 31 is a fragmentary, cross-sectional view of the jack assembly ofFIG. 30 in a partially stent-expanded state;

FIG. 32 is a fragmentary, cross-sectional view of the jack assembly ofFIG. 31 with the needle sub-assembly in an actuated state with extensionof the needle;

FIG. 33 is a fragmentary, cross-sectional view of the jack assembly ofFIG. 32 with the drive sub-assembly in a disconnected state and theneedle sub-assembly in a disconnected state;

FIG. 34 is a fragmentary, perspective view of the jack assembly of FIG.33 with the extended needle rotated slightly to the right of the figure.

FIG. 35 is a fragmentary, perspective view of the jack assembly of FIG.34 rotated to the right by approximately 45 degrees;

FIG. 36 is a fragmentary, partially cross-sectional, perspective viewfrom above the jack assembly of FIG. 30 showing the interior of thedistal drive block;

FIG. 37 is a fragmentary, enlarged, cross-sectional view of the jackassembly of FIG. 33;

FIG. 38 is a photograph of a perspective view from above the upstreamend of another exemplary embodiment of an actively controllable stentgraft according to the invention in a substantially contracted state;

FIG. 39 is a photograph of a perspective view of the stent graft of FIG.38 in a partially expanded state;

FIG. 40 is a photograph of a perspective view of the stent graft of FIG.38 in an expanded state;

FIG. 41 is a photograph of a side perspective view of the stent graft ofFIG. 38 in an expanded state;

FIG. 42 is a photograph of a perspective view of another exemplaryembodiment of an actively controllable stent for a stent graft accordingto the invention in a substantially expanded state with integralupstream anchors;

FIG. 43 is a photograph of a perspective view of the stent of FIG. 42 ina partially expanded state;

FIG. 44 is a photograph of a perspective view of the stent of FIG. 42 inanother partially expanded state;

FIG. 45 is a photograph of a perspective view of the stent of FIG. 42 ina substantially contracted state;

FIG. 46 is a photograph of a side perspective view of another exemplaryembodiment of an actively controllable stent for a stent graft accordingto the invention in a substantially expanded state with a tapered outerexterior;

FIG. 47 is a photograph of a top perspective view of the stent of FIG.46;

FIG. 48 is a photograph of a perspective view of the stent of FIG. 46from above a side;

FIG. 49 is a photograph of a perspective view of the stent of FIG. 46from above a side with the stent in a partially expanded state;

FIG. 50 is a photograph of a perspective view of the stent of FIG. 46from above a side with the stent in a substantially contracted state;

FIG. 51 is a photograph of an exemplary embodiment of a low-profilejoint assembly for actively controllable stents/stent grafts accordingto the invention;

FIG. 52 is a photograph of struts of the joint assembly of FIG. 51separated from one another;

FIG. 53 is a photograph of a rivet of the joint assembly of FIG. 51;

FIG. 54 is a fragmentary, side perspective view of another exemplaryembodiment of an actively controllable stent system for a stent graftaccording to the invention in a substantially expanded state with atapered outer exterior;

FIG. 55 is a side perspective view of the stent system of FIG. 54;

FIG. 56 is a side elevational view of the stent system of FIG. 54;

FIG. 57 is a side elevational view of the stent system of FIG. 54 in asubstantially contracted state;

FIG. 58 is a side elevational view of another exemplary embodiment of aportion of an actively controllable stent system for a stent graftaccording to the invention in a substantially contracted state;

FIG. 59 is a perspective view of the stent system portion of FIG. 58;

FIG. 60 is a top plan view of the stent system portion of FIG. 58;

FIG. 61 is a side perspective view of the stent system portion of FIG.58 in a partially expanded state;

FIG. 62 is a top plan view of the stent system portion of FIG. 61;

FIG. 63 is a side elevational view of the stent system portion of FIG.61;

FIG. 64 is a perspective view of a downstream side of an exemplaryembodiment of a replacement valve assembly according to the invention inan expanded state;

FIG. 65 is a side elevational view of the valve assembly of FIG. 64;

FIG. 66 is a fragmentary, perspective view of a delivery systemaccording to the invention for the aortic valve assembly of FIG. 64 withthe aortic valve assembly in the process of being implanted and in theright iliac artery;

FIG. 67 is a fragmentary, perspective view of the delivery system andaortic valve assembly of FIG. 66 with the aortic valve assembly in theprocess of being implanted and in the abdominal aorta;

FIG. 68 is a fragmentary, perspective view of the delivery system andaortic valve assembly of FIG. 66 with the aortic valve assembly in theprocess of being implanted and being adjacent the aortic valveimplantation site;

FIG. 69 is a fragmentary, perspective view of the delivery system andaortic valve assembly of FIG. 66 with the aortic valve assemblyimplanted in the heart;

FIG. 70 is a fragmentary, enlarged, perspective view of the deliverysystem and the aortic valve assembly of FIG. 69 implanted at an aorticvalve implantation site;

FIG. 71 is a perspective view of a side of another exemplary embodimentof a replacement aortic valve assembly according to the invention in anexpanded state;

FIG. 72 is a perspective view of the replacement aortic valve assemblyof FIG. 71 from above a downstream side thereof;

FIG. 73 is a perspective view of the replacement aortic valve assemblyof FIG. 71 from above a downstream end thereof;

FIG. 74 is a perspective view of the replacement aortic valve assemblyof FIG. 71 from below an upstream end thereof;

FIG. 75 is a perspective view of an enlarged portion of the replacementaortic valve assembly of FIG. 74;

FIG. 76 is a perspective view of the replacement aortic valve assemblyof FIG. 71 from a side thereof with the graft material removed;

FIG. 77 is a perspective view of the replacement aortic valve assemblyof FIG. 76 from above a downstream side thereof;

FIG. 78 is a side elevation, vertical cross-sectional view of thereplacement aortic valve assembly of FIG. 76;

FIG. 79 is a perspective view of the replacement aortic valve assemblyof FIG. 76 from a side thereof with the valve material removed, with thestent lattice in an expanded state;

FIG. 80 is a perspective view of the replacement aortic valve assemblyof FIG. 79 with the stent lattice in an intermediate expanded state;

FIG. 81 is a perspective view of the replacement aortic valve assemblyof FIG. 79 with the stent lattice in an almost contracted state;

FIG. 82 is a downstream plan view of the replacement aortic valveassembly of FIG. 79 in an intermediate expanded state;

FIG. 83 is an enlarged downstream plan view of a portion of thereplacement aortic valve assembly of FIG. 79 in an expanded state;

FIG. 84 is a side elevational view of the replacement aortic valveassembly of FIG. 79 in an expanded state, with graft material removed,and with distal portions of an exemplary embodiment of a valve deliverysystem;

FIG. 85 is a perspective view of an exemplary embodiment of a jackassembly of the replacement aortic valve assembly of FIG. 84 from a sidethereof with the valve delivery system sectioned;

FIG. 86 is a perspective view of the replacement aortic valve assemblyof FIG. 79 in an expanded state, with graft material removed, and withdistal portions of another exemplary embodiment of a valve deliverysystem;

FIG. 87 is a fragmentary, enlarged perspective view of the replacementaortic valve assembly of FIG. 86 with graft material shown;

FIG. 88 is a fragmentary, enlarged, perspective view of the deliverysystem and the aortic valve assembly of FIG. 71 implanted at an aorticvalve implantation site;

FIG. 89 is a fragmentary, side elevational view of another exemplaryembodiment of an actively controllable and tiltable stent graft systemaccording to the invention in a partially expanded state and anon-tilted state;

FIG. 90 is a fragmentary, side elevational view of the system of FIG. 89in a partially tilted state from a front thereof;

FIG. 91 is a fragmentary, side elevational view of the system of FIG. 90in another partially tilted state;

FIG. 92 is a fragmentary, side elevational view of the system of FIG. 90in yet another partially tilted state;

FIG. 93 is a fragmentary, perspective view of the system of FIG. 90 inyet another partially tilted state;

FIG. 94 is a fragmentary, partially cross-sectional, side elevationalview of another exemplary embodiment of an actively controllable andtiltable stent graft system according to the invention in an expandedstate and a partially front-side tilted state

FIG. 95 is a fragmentary, perspective view of the system of FIG. 94 in anon-tilted state;

FIG. 96 is a fragmentary, side elevational view of the system of FIG. 94in a non-tilted state;

FIG. 97 is a fragmentary, side elevational view of the system of FIG. 96rotated approximately 90 degrees with respect to the view of FIG. 96;

FIG. 98 is a fragmentary, longitudinally cross-sectional, sideelevational view of the system of FIG. 94 showing the rear half of thesystem and a tubular graft material in a non-tilted state and partiallyexpanded state;

FIG. 99 is fragmentary, partially cross-sectional, perspective view ofthe system of FIG. 94 showing the rear half of the tubular graftmaterial and in a non-tilted state and a partially expanded state;

FIG. 100 is a fragmentary, partially cross-sectional, side elevationalview of the system of FIG. 94 showing the rear half of graft materialfor a bifurcated vessel and in a non-tilted state;

FIG. 101 is a fragmentary, partially cross-sectional, side elevationalview of the system of FIG. 100 in an expanded state and a partiallytilted state;

FIG. 102 is a fragmentary, partially cross-sectional, side elevationalview of the system of FIG. 101 rotated approximately 45 degrees withrespect to the view of FIG. 101;

FIG. 103 is a fragmentary, side perspective view of another exemplaryembodiment of an actively controllable stent graft system according tothe invention in an expanded state;

FIG. 104 is a fragmentary, side elevational view of the system of FIG.103;

FIG. 105 is a fragmentary, front elevational and partiallycross-sectional view of a self-contained, self-powered, activelycontrollable stent graft delivery and integral control system accordingto the invention with the prosthesis in an expanded state with the graftmaterial in cross-section showing a rear half thereof;

FIG. 106 is a perspective view of the control portion of the system ofFIG. 105 as a wireless sub-system;

FIG. 107 is a fragmentary, front elevational view of another exemplaryembodiment of a self-contained, self-powered, actively controllablestent graft delivery and separate tethered control system according tothe invention with different controls and with the prosthesis in anexpanded state;

FIG. 108 is a fragmentary, perspective view of a control handle of anexemplary embodiment of a self-contained, self-powered, activelycontrollable prosthesis delivery device according to the invention fromabove a left side thereof with the upper handle half and power packremoved;

FIG. 109 is a fragmentary, vertically cross-sectional view of the handleof FIG. 108 with the power pack removed;

FIG. 110 is a fragmentary, enlarged, vertically cross-sectional andperspective view of a sheath-movement portion of the handle of FIG. 108from above a left side thereof;

FIG. 111 is a fragmentary, further enlarged, vertically cross-sectionalview of the sheath-movement portion of FIG. 110 from below a left sidethereof;

FIG. 112 is a fragmentary, enlarged, vertically cross-sectional view ofa power portion of the handle of FIG. 108 viewed from a proximal sidethereof;

FIG. 113 is a fragmentary, perspective view of a needle control portionof the handle of FIG. 108 from above a distal side with the upper handlehalf and power pack removed and with the needle control in alattice-contracted and needle-stowed position;

FIG. 114 is a fragmentary, perspective view of the needle controlportion of the handle of FIG. 113 with the needle control in alattice-expanded and needle-stowed position;

FIG. 115 is a fragmentary, perspective view of the needle controlportion of the handle of FIG. 114 with the needle control in aneedle-extended position;

FIG. 116 is a fragmentary, perspective view of an engine portion of thehandle of FIG. 108 from above a left side thereof with the upper handlehalf removed;

FIG. 117 is a fragmentary, enlarged, vertically cross-sectional view ofthe engine portion of FIG. 116 viewed from a proximal side thereof;

FIG. 118 is a fragmentary, enlarged, vertically cross-sectional view ofthe engine portion of the handle portion of FIG. 117 viewed from adistal side thereof;

FIG. 119 is a flow diagram of an exemplary embodiment of a procedure forimplanting an abdominal aorta prosthesis according to the invention;

FIG. 120 is a perspective view of an exemplary embodiment of aself-expanding/forcibly-expanding lattice of an implantable stentassembly having nine lattice segments in a native, self-expandedposition with jack screw assemblies disposed between adjacent pairs ofrepeating portions of the lattice, with jack screws through a wall ofthe lattice, and with each jack screw backed out in a thread-non-engagedstate to allow crimp of lattice for loading into a stent deliverysystem;

FIG. 121 is a perspective view of the lattice of FIG. 120 in acontracted/crimped state for loading into the stent delivery system witheach jack screw in a thread-non-engaged state;

FIG. 122 is a perspective view of the lattice of FIG. 121 after beingallowed to return to the native position of the lattice in a deploymentsite with each jack screw in a thread-engaged state for further outwardexpansion or inward contraction of the lattice;

FIG. 123 is a perspective view of the lattice of FIG. 122 partiallyexpanded from the state shown in FIG. 122 with each jack screw in athread-engaged state for further outward expansion or inward contractionof the lattice;

FIG. 124 is a tilted perspective view of the lattice of FIG. 123partially expanded from the state shown in FIG. 123 with each jack screwin a thread-engaged state for further outward expansion or inwardcontraction of the lattice;

FIG. 125 is a perspective view of the lattice of FIG. 124 furtherexpanded near a maximum expansion of the lattice with each jack screw ina thread-engaged state;

FIG. 126 is a fragmentary, enlarged perspective and longitudinalcross-sectional view of a portion of two adjacent halves of repeatingportions of an alternative exemplary embodiment of aself-expanding/forcibly-expanding lattice of an implantable stentassembly with a separate jack screw assembly connecting the two adjacenthalves and with a lattice-disconnect tube of a stent delivery system inan engaged state covering a pair of drive screw coupler parts thereinand with the jack screw in a thread-engaged state for further outwardexpansion or inward contraction of the lattice;

FIG. 127 is a fragmentary, further enlarged portion of the two adjacenthalves of the repeating portions and intermediate jack screw assembly ofFIG. 125 with the disconnect tube in a disengaged state with respect tothe pair of drive screw coupler parts;

FIG. 128 is a fragmentary enlarged portion of the two adjacent halves ofthe repeating portions and intermediate jack screw assembly of FIG. 125with the disconnect tube in a disengaged state and with the pair ofdrive screw coupler parts disconnected from one another;

FIG. 129 is a perspective view of another exemplary embodiment of aself-expanding/forcibly-expanding lattice of an implantable stentassembly having nine separate lattice segments with an exemplaryembodiment of a proximal disconnect block of a stent delivery system asan alternative to the disconnect tube of FIGS. 126 to 128 with theproximal disconnect block in an engaged state covering a pair of drivescrew coupler parts therein and with each jack screw in a thread-engagedstate for further outward expansion or inward contraction of thelattice;

FIG. 130 is a perspective view of the lattice of FIG. 129 with theproximal disconnect blocks of the delivery system disconnected from thelattice with the proximal disconnect block in a disengaged state withrespect to the pair of drive screw coupler parts and illustrating howall of the pairs of drive screw coupler parts can be coupled forsimultaneous release;

FIG. 131 is a perspective view of another exemplary embodiment of aself-expanding/forcibly-expanding lattice of an implantable stentassembly having nine separate lattice segments connected to intermediatetubes for jack screws with each jack screw in a thread-engaged state forfurther outward expansion or inward contraction of the lattice;

FIG. 132 is a top plan view of the lattice of FIG. 131;

FIG. 133 is a perspective view of another exemplary embodiment of aself-expanding/forcibly-expanding lattice of an implantable stentassembly having nine lattice segments with locally thicker sections oflattice to accommodate and connect to non-illustrated jack screwassemblies;

FIG. 134 is a perspective view of another exemplary embodiment of aself-expanding/forcibly-expanding lattice of an implantable stentassembly having nine lattice segments with bent-over tabs for connectingto non-illustrated jack screw assemblies;

FIG. 135 is a perspective view of another exemplary embodiment of aself-expanding/forcibly-expanding lattice of an implantable valveassembly having six lattice segments in an expanded position with jackscrew assemblies disposed between adjacent pairs of repeating portionsof the lattice and having three valve leaflets and jack screws through awall of the lattice in a thread-non-engaged state of the jack screw;

FIG. 136 is a plan view of the valve assembly of FIG. 135;

FIG. 137 is a perspective view of the valve assembly of FIG. 135 in apartially compressed state of the lattice without the valve leaflets andwith each jack screw in a thread-non-engaged state;

FIG. 138 is a perspective view of another exemplary embodiment of aself-expanding/forcibly-expanding lattice of an implantable valveassembly having six lattice segments in a native, self-expanded positionwith jack screw assemblies attached at an interior surface betweenadjacent pairs of segments of the lattice without the valve leaflets andwith each of the jack screws in a thread-engaged state for furtheroutward expansion or inward contraction of the lattice;

FIG. 139 is a perspective view of the lattice of FIG. 138 in acontracted/crimped state for loading into the stent delivery system witheach jack screw in a thread-non-engaged state;

FIG. 140 is a tilted perspective view of the lattice of FIG. 138;

FIG. 141 is a perspective view of the lattice of FIG. 138 partiallyexpanded from the state shown in FIG. 138 with each jack screw in anengaged state for further outward expansion or inward contraction of thelattice;

FIG. 142 is a perspective view of the lattice of FIG. 138 furtherexpanded near a maximum expansion of the lattice with each jack screw inan engaged state for further outward expansion or inward contraction ofthe lattice;

FIG. 143 is a side elevational view of another exemplary embodiment of aself-expanding/forcibly-expanding lattice of an implantable stentassembly having nine lattice segments in a native, self-expandedposition with jack screw assemblies integral with the stent assembly andwith each of the jack screws in a thread-engaged state for outwardexpansion and inward contraction of the lattice and with a portion ofthe stent assembly delivery system having connector control tubes withone connector control tube shown in transparent form;

FIG. 144 is a top plan view of the lattice of FIG. 143;

FIG. 145 is a perspective view of the lattice of FIG. 143 from above;

FIG. 146 is a side elevational view of the lattice of FIG. 143 with theconnector control tubes of the delivery system in a non-engaged stateand the respective connector portions of the jack screw assemblies andthe delivery system shown in a disconnected state after implantation;

FIG. 147 is an enlarged, fragmentary, perspective view of a portion ofthe lattice of FIG. 143 from outside a side thereof;

FIG. 148 is an enlarged, fragmentary, perspective view of a portion ofthe lattice of FIG. 143 from above a top thereof;

FIG. 149 is a perspective view of the lattice of FIG. 143 from above aside thereof with the lattice expanded by the jack screw assembliesalmost to a fullest expanded extent;

FIG. 150 is a perspective view of the lattice of FIG. 143 from a sidethereof with the lattice contracted by the jack screw assemblies almostto a fullest contracted extent;

FIG. 151 is a perspective view of the lattice of FIG. 150 from a sidethereof tilted with respect to FIG. 150;

FIG. 152 is a fragmentary, enlarged, perspective view of an upperportion of the lattice of FIG. 151;

FIG. 153 is a fragmentary, enlarged, perspective and verticalcross-sectional view of an intermediate portion of the lattice of FIG.150;

FIG. 154 is a perspective view of the lattice of FIG. 143 beforemanufacture of the stent assembly and illustrating one exemplaryembodiment for manufacturing the lattice of the stent assembly;

FIG. 155 is a side elevational view of another exemplary embodiment of aself-expanding/forcibly-expanding lattice of an implantable stentassembly having six lattice segments in a partially expanded state witheach of the jack screws in a thread-engaged state for further outwardexpansion and in a slacked state for inward contraction of the lattice,with jack screw assemblies integral with the stent assembly throughkey-hole slots in the lattice, and with an alternative exemplaryembodiment of outer lattice fixation paddles bent outwards to shape thelattice into a longitudinal hourglass;

FIG. 156 is a top plan view of the implantable stent assembly of FIG.155 showing the key-hole slots in the lattice for the jack screwassemblies;

FIG. 157 is a perspective view of the lattice of FIG. 156 from above aside of the top thereof;

FIG. 158 is a top plan view of the lattice of FIG. 156;

FIG. 159 is an enlarged, fragmentary, perspective view of a portion of atop of the lattice of FIG. 156;

FIG. 160 is a perspective view of an upper portion of the lattice ofFIG. 156 from the outside of a side thereof;

FIG. 161 is a side elevational view of the lattice of FIG. 156 in aself-expanded, natural state with each of the jack screws in athread-engaged state for outward expansion and in a slacked state forinward contraction of the lattice;

FIG. 162 is a side elevational view of the lattice of FIG. 161 in aself-expanded, natural state with each of the jack screws in athread-engaged state for inward contraction and in a slacked state foroutward expansion of the lattice;

FIG. 163 is a side elevational view of the lattice of FIG. 162 in aforcibly contracted state with each of the jack screws in athread-engaged state for further inward contraction or outward expansionof the lattice;

FIG. 164 is a side elevational view of the lattice of FIG. 163 in aforcibly contracted state by a delivery sheath;

FIG. 165 is a side elevational view of the lattice of FIG. 161 in aforcibly expanded state with each of the jack screws in a thread-engagedstate for further outward expansion or inward contraction of thelattice;

FIG. 166 is a side elevational view of the lattice of FIG. 165 in afurther forcibly expanded state with each of the jack screws in athread-engaged state for further outward expansion or inward contractionof the lattice;

FIG. 167 is a side elevational view of another exemplary embodiment of aself-expanding/forcibly-expanding lattice of an implantable stentassembly having six lattice segments in a forcibly expanded positionwith jack screw assemblies having intermediate jack screw nutslongitudinally staggered about the circumference of the lattice;

FIG. 168 is a fragmentary, perspective view of the lattice of FIG. 167in a forcibly contracted position showing the staggered positions of thejack screw nuts;

FIG. 169 is a fragmentary, perspective view of a distal end of anexemplary embodiment delivery system containing the lattice of FIGS. 156to 166 in a forcibly expanded and implantation-ready state;

FIG. 170 is a fragmentary, side elevational view of the delivery systemand lattice of FIG. 169 with the connector control sub-assembly in alattice-connected state;

FIG. 171 is a fragmentary, side elevational view of the delivery systemand lattice of FIG. 169 with the connector control sub-assembly in alattice-disconnected state with each of the disconnect tubesrespectively retracted proximally from each of the jack-screw-connectorpairs but before the jack-screw-connector pairs disconnect from oneanother;

FIG. 172 is a fragmentary, side elevational view of the delivery systemand lattice of FIG. 169 with the connector control sub-assembly in alattice-disconnected state with each of the jack-screw-connector pairsdisconnected from one another and with the jack-screw-connector portionof the delivery system separated from the lattice;

FIG. 173 is a fragmentary, enlarged perspective view of theconnector-control portion of the delivery system and lattice of FIGS.169 to 172 with two control coils for two connector tubes removed toshow distal and proximal sleeves residing in respective counter-bores ofa tube-control puck and with a distal portion of the respective twojack-screw-control wires removed;

FIG. 174 is a photograph of a fragmentary, perspective view from a sideof an exemplary embodiment of a delivery system and lattice of FIGS. 167to 168 in a forcibly expanded state of the lattice;

FIG. 175 is a photograph of a fragmentary, perspective view from a sideof the delivery system and lattice of FIG. 174 rotated with respect toFIG. 174;

FIG. 176 is a photograph of a fragmentary, perspective view from a sideof the delivery system and lattice of FIG. 174;

FIG. 177 is a photograph of a fragmentary, perspective view from a sideof the delivery system and lattice of FIG. 174 rotated with respect toFIG. 174;

FIG. 178 is a photograph of a fragmentary, perspective view from a sideof a lattice control portion of the delivery system of FIG. 174;

FIG. 179 is a photograph of a fragmentary, enlarged, perspective viewfrom a side of a distal portion of the lattice control portion of thedelivery system of FIG. 178;

FIG. 180 is a photograph of a fragmentary, perspective view from a sideof a proximal portion of the lattice control portion of the deliverysystem of FIG. 178;

FIG. 181 is a photograph of a perspective view from a side of anexemplary embodiment of a self-expanding/forcibly-expanding implantableheart valve assembly having nine lattice segments in an expanded stateand with valve leaflets in an open state;

FIG. 182 is a photograph of a side view of the heart valve assembly ofFIG. 181;

FIG. 183 is a photograph of a side view of the heart valve assembly ofFIG. 181 rotated with respect to the view shown in FIG. 182;

FIG. 184 is a photograph of a side view of the heart valve assembly ofFIG. 183;

FIG. 185 is a photograph of an upstream plan view of the heart valveassembly of FIG. 181;

FIG. 186 is a photograph of a downstream plan view of the heart valveassembly of FIG. 181;

FIG. 187 is a photograph of a downstream plan view of an exemplaryembodiment of a self-expanding/forcibly-expanding implantable heartvalve assembly having six lattice segments in an expanded state and withvalve leaflets in an open state;

FIG. 188 is a photograph of a valve leaflet assembly of the heart valveassembly of FIG. 187;

FIG. 189 is a photograph of a downstream perspective view of the heartvalve assembly of FIG. 187;

FIG. 190 is a photograph of a side perspective view of the heart valveassembly of FIG. 187;

FIG. 191 is a photograph of a downstream perspective view of the heartvalve assembly of FIG. 187 forcibly expanded in an exemplary embodimentof a delivery system;

FIG. 192 is a photograph of a perspective view of the heart valveassembly of FIG. 187;

FIG. 193 is a photograph of an enlarged, perspective view from a side ofan exemplary embodiment of a self-expanding/forcibly-expandingimplantable heart valve assembly;

FIG. 194 is a photograph of an enlarged perspective view from a side ofthe heart valve assembly of FIG. 193 rotated with respect to the view ofFIG. 193;

FIG. 195 is a photograph of an enlarged portion of an exemplaryembodiment of a graft portion of a heart valve assembly in anunstretched state;

FIG. 196 is a photograph of a further enlarged first portion of thegraft of FIG. 195;

FIG. 197 is a photograph of a further enlarged second portion of thegraft of FIG. 195;

FIG. 198 is a photograph of the graft portion of the heart valveassembly of FIG. 195 in stretched with a 100% extension;

FIG. 199 is a photograph of the graft portion of the heart valveassembly of FIG. 198 after the stretch is removed;

FIG. 200 is a cross-sectional view of an exemplary embodiment of anadjustable valve leaflet sub-assembly of a heart valve assembly;

FIG. 201 is a cross-sectional view of another exemplary embodiment of anadjustable valve leaflet sub-assembly of a heart valve assembly;

FIG. 202 is a cross-sectional view of another exemplary embodiment of anadjustable valve leaflet sub-assembly of a heart valve assembly;

FIG. 203 is a side elevational view of an exemplary embodiment of anadjustment shim that, when moved longitudinally, takes up more or letsout more of the valve leaflet edge to shorten or lengthen the overlapportions of the valve leaflets.

FIG. 204 is a fragmentary, perspective view of an exemplary embodimentof a self-expanding/forcibly-expanding implantable stent assembly havingsix lattice segments in an expanded state and with an alternativeembodiment of a jack screw assembly having an outer-facing jack screwkeyhole;

FIG. 205 is a side elevational view of the implantable stent assembly ofFIG. 204 with a valve sub-assembly;

FIG. 206 is a fragmentary, enlarged portion of the outer-facing jackscrew keyhole of the stent assembly of FIG. 204;

FIG. 207 is a fragmentary, enlarged, top plan and partially hidden viewof an inner-facing jack screw keyhole;

FIG. 208 is a fragmentary, enlarged, perspective view of the stentassembly of FIG. 204 with an exemplary embodiment of a valve leafletcommisure connector;

FIG. 209 is a side perspective view of an exemplary embodiment of aself-expanding/forcibly-expanding implantable valve assembly having sixlattice segments in an expanded state and with an alternative embodimentof securing the valve sub-assembly to the lattice and graft;

FIG. 210 is a perspective view of a downstream side of theself-expanding/forcibly-expanding implantable valve assembly of FIG.209;

FIG. 211 is a perspective view of an upstream side of theself-expanding/forcibly-expanding implantable valve assembly of FIG.209;

FIG. 212 is a photograph of an exemplary embodiment of aself-expanding/forcibly-expanding implantable valve assembly connectedto a distal end of an exemplary embodiment of a delivery system with thevalve assembly and the delivery approximately in an implantation state;

FIG. 213 is a photograph of the valve assembly and delivery system ofFIG. 212 with the valve assembly in an intermediate re-sheathing statewhere the lattice-disconnector tubes partially re-sheathed;

FIG. 214 is a photograph of the valve assembly and delivery system ofFIG. 212 with the valve assembly in an intermediate re-sheathing statewhere the lattice-disconnector tubes are re-sheathed and a proximalportion of the valve assembly is re-sheathed;

FIG. 215 is a photograph of the valve assembly and delivery system ofFIG. 212 with the valve assembly in an intermediate re-sheathing statewhere the valve assembly is half re-sheathed;

FIG. 216 is a photograph of the valve assembly and delivery system ofFIG. 212 with the valve assembly in an intermediate re-sheathing statewhere the valve assembly is approximately three-quarters re-sheathed;

FIG. 217 is a photograph of the valve assembly and delivery system ofFIG. 212 with the valve assembly re-sheathed into the delivery catheter;

FIG. 218 is a photograph of a manufacturing process for creating adistal end of an exemplary embodiment of a delivery catheter sized tofit within an 18-French hole;

FIG. 219 is a photograph of an end plan view of the distal end of thedelivery catheter of FIG. 218 without the remainder of the deliverysystem;

FIG. 220 is a photograph of a side perspective view of the distal end ofthe delivery catheter of FIG. 218 after the valve assembly has beenextended and/or re-sheathed;

FIG. 221 is a photograph of an exemplary embodiment of aself-expanding/forcibly-expanding implantable stent assembly having sixlattice segments in an intermediate expanded state without a valvesub-assembly and inside an irregular-shaped implantation site;

FIG. 222 is a photograph of the stent assembly of FIG. 221 in an furtherintermediate expanded state;

FIG. 223 is a photograph of the stent assembly of FIG. 221 in an furtherintermediate expanded state;

FIG. 224 is a photograph of the stent assembly of FIG. 221 in animplanted state within the irregular-shaped implantation site;

FIG. 225 is a process flow diagram of an exemplary embodiment of amethod for controlling implantation of a self-expanding andforcibly-expanding device according to the described embodiments

FIG. 226 is a fragmentary, exploded, perspective view of an exemplaryembodiment of a distal control handle for implanting a self-expandingand forcibly-expanding device;

FIG. 227 is a fragmentary, exploded, perspective view of a distalportion of the distal control handle of FIG. 226 from a side thereof;

FIG. 228 is a fragmentary, exploded, perspective view of a proximalportion of the distal control handle of FIG. 226 from a side thereof;

FIG. 229 is a perspective view of an alternative embodiment of thedistal control handle of FIG. 226 from above a side thereof;

FIG. 230 is a fragmentary, perspective view of a proximal portion of thedistal control handle of FIG. 229 from above a side thereof;

FIG. 231 is a side elevational view of an exemplary embodiment of aself-expanding and forcibly-expanding implant;

FIG. 232 is a fragmentary, side elevational view of the self-expandingand forcibly-expanding implant of FIG. 231 inside a valve orifice;

FIG. 233 is a fragmentary, side elevational view of the self-expandingand forcibly-expanding implant of FIG. 231 inside a cylindrical vessel;

FIG. 234 is a side elevational view of an exemplary embodiment of aself-expanding and forcibly-expanding implant with a barbell-shapedextension on a distal end thereof;

FIG. 235 is a side elevational view of an exemplary embodiment of aself-expanding and forcibly-expanding implant with a bulb-shapedextension on a distal end thereof;

FIG. 236 is a fragmentary, diagrammatic cross-sectional view of a hearthaving an atrial septal defect;

FIG. 237 is a fragmentary, diagrammatic cross-sectional view of theheart of FIG. 236 having an exemplary embodiment of a self-expanding andforcibly-expanding implant implanted within the atrial septal defect;

FIG. 238 is a fragmentary, diagrammatic cross-sectional view of a heartin which a WATCHMAN® device is implanted within the left atrialappendage;

FIG. 239 is a fragmentary, diagrammatic, enlarged cross-sectional viewof the heart of FIG. 238 with a view of the left atrial appendage;

FIG. 240 is a fragmentary, diagrammatic cross-sectional view of a leftatrium and a left atrial appendage of a heart with a self-expanding andforcibly-expanding implant partially expanded in the appendage;

FIG. 241 is a fragmentary, diagrammatic cross-sectional view of a hearthaving a left ventricular aneurysm;

FIG. 242 is a fragmentary illustration of the arterial and venouscirculation of the human legs;

FIG. 243 is a perspective view of an alternative embodiment of a distalcontrol handle according to the invention from above a right rearthereof and with the distal prosthesis delivery system removed;

FIG. 244 is a right side elevational view of the distal control handleof FIG. 243;

FIG. 245 is a left side elevational view of the distal control handle ofFIG. 243;

FIG. 246 is a top plan view of the distal control handle of FIG. 243;

FIG. 247 is a bottom plan view of the distal control handle of FIG. 243;

FIG. 248 is a rear elevational view of the distal control handle of FIG.243;

FIG. 249 is a perspective view of the distal control handle of FIG. 243from above the right rear corner;

FIG. 250 is a perspective view of the distal control handle of FIG. 243from above the left rear;

FIG. 251 is a perspective view of the distal control handle of FIG. 243from above the right upper front side with a top half of a casingremoved and with the distal prosthesis delivery system removed;

FIG. 252 is a perspective view of a motor and transmission assembly ofthe distal control handle of FIG. 251 from above;

FIG. 253 is a perspective view of the front of the motor assembly of thedistal control handle of FIG. 251 with a distal transmission coverremoved;

FIG. 254 is a perspective view of the front of the motor assembly of thedistal control handle of FIG. 251 with a proximal transmission cover andmotors removed;

FIG. 255 is a perspective view of the rear of the motor assembly of thedistal control handle of FIG. 251 with the proximal transmission coverand motors removed;

FIG. 256 is a photograph of the rear of the distal control handle ofFIG. 243;

FIG. 257 is a photograph of the distal control handle of FIG. 243 fromabove with the top half of the casing removed;

FIG. 258 is a photograph of a delivery system with the distal controlhandle of FIG. 243 from in front of a left side thereof with the tophalf of the casing removed;

FIG. 259 is a photograph of the delivery system of FIG. 258 from abovethe left side thereof;

FIG. 260 is a photograph of the delivery system of FIG. 258 from behinda left side thereof;

FIG. 261 is a multi-variable display of an exemplary embodiment of amethod for determining a characteristic curve of an implant fordetecting a native annulus size according to the invention;

FIG. 262 is a multi-variable display of the method for determining thecharacteristic curve of FIG. 261 with an different implant;

FIG. 263 is a multi-variable display of the method for determining thecharacteristic curve of FIG. 261 with an different implant;

FIG. 264 is a multi-variable display of a method for detecting a nativeannulus size according to the invention;

FIG. 265 is a fluoroscopic image of an exemplary embodiment of adelivery system with a self-expanding and forcibly-expanding aorticvalve implant in a partially expanded state;

FIG. 266 is a fluoroscopic image of the delivery system and valveimplant of FIG. 265 rotated counter-clockwise;

FIG. 267 is a fluoroscopic image of the delivery system and valveimplant of FIG. 265 rotated clockwise;

FIG. 268 is a fluoroscopic image of the delivery system and valveimplant of FIG. 265 expanded to an implantation position;

FIG. 269 is a fragmentary perspective view of an exemplary embodiment anangular correction device of a distal end of a stent delivery system;

FIG. 270 is a fluoroscopic image of an exemplary embodiment of anangular correction device at a distal end of a delivery system with aself-expanding and forcibly-expanding aortic valve implant in apartially expanded state;

FIG. 271 is a fluoroscopic image of the angular correction device, thedelivery system, and the valve implant of FIG. 270 expanded to animplantation position; and

FIG. 272 is a fluoroscopic image of the angular correction device, thedelivery system, and the valve implant of FIG. 270 with the angularcorrection device actuated to rotate the implant clockwise.

DETAILED DESCRIPTION OF THE INVENTION

As required, detailed embodiments of the present invention are disclosedherein; however, it is to be understood that the disclosed embodimentsare merely exemplary of the invention, which can be embodied in variousforms. Therefore, specific structural and functional details disclosedherein are not to be interpreted as limiting, but merely as a basis forthe claims and as a representative basis for teaching one skilled in theart to variously employ the present invention in virtually anyappropriately detailed structure. Further, the terms and phrases usedherein are not intended to be limiting; but rather, to provide anunderstandable description of the invention. While the specificationconcludes with claims defining the features of the invention that areregarded as novel, it is believed that the invention will be betterunderstood from a consideration of the following description inconjunction with the drawing figures, in which like reference numeralsare carried forward.

Alternate embodiments may be devised without departing from the spiritor the scope of the invention. Additionally, well-known elements ofexemplary embodiments of the invention will not be described in detailor will be omitted so as not to obscure the relevant details of theinvention.

Before the present invention is disclosed and described, it is to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only and is not intended to belimiting. The terms “a” or “an”, as used herein, are defined as one ormore than one. The term “plurality,” as used herein, is defined as twoor more than two. The term “another,” as used herein, is defined as atleast a second or more. The terms “including” and/or “having,” as usedherein, are defined as comprising (i.e., open language). The term“coupled,” as used herein, is defined as connected, although notnecessarily directly, and not necessarily mechanically.

Relational terms such as first and second, top and bottom, and the likemay be used solely to distinguish one entity or action from anotherentity or action without necessarily requiring or implying any actualsuch relationship or order between such entities or actions. The terms“comprises,” “comprising,” or any other variation thereof are intendedto cover a non-exclusive inclusion, such that a process, method,article, or apparatus that comprises a list of elements does not includeonly those elements but may include other elements not expressly listedor inherent to such process, method, article, or apparatus. An elementproceeded by “comprises . . . a” does not, without more constraints,preclude the existence of additional identical elements in the process,method, article, or apparatus that comprises the element.

As used herein, the term “about” or “approximately” applies to allnumeric values, whether or not explicitly indicated. These termsgenerally refer to a range of numbers that one of skill in the art wouldconsider equivalent to the recited values (i.e., having the samefunction or result). In many instances these terms may include numbersthat are rounded to the nearest significant figure.

The terms “program,” “programmed”, “programming,” “software,” “softwareapplication,” and the like as used herein, are defined as a sequence ofinstructions designed for execution on a computer system. A “program,”“software,” “computer program,” or “software application” may include asubroutine, a function, a procedure, an object method, an objectimplementation, an executable application, an applet, a servlet, asource code, an object code, a shared library/dynamic load libraryand/or other sequence of instructions designed for execution on acomputer system.

Herein various embodiments of the present invention are described. Inmany of the different embodiments, features are similar. Therefore, toavoid redundancy, repetitive description of these similar features maynot be made in some circumstances. It shall be understood, however, thatdescription of a first-appearing feature applies to the later describedsimilar feature and each respective description, therefore, is to beincorporated therein without such repetition.

Described now are exemplary embodiments of the present invention.Referring now to the figures of the drawings in detail and first,particularly to FIGS. 1 to 19, there is shown a first exemplaryembodiment of an actively controllable stent deployment system 100according to the invention. Even though this exemplary embodiment isillustrated as a stent deployment system without the presence of a stentgraft, this embodiment is not to be considered as limited thereto. Anystent graft embodiment according the invention as disclosed herein canbe used in this embodiment. The stent graft is not shown in thesefigures for clarity. Further, as used herein, the terms “stent” and“stent graft” are used herein interchangeably. Therefore, any embodimentwhere a stent is described without referring to a graft should beconsidered as referring to a graft additionally or in the alternative,and any embodiment where both a stent and a graft are described andshown should be considered as also referring to an embodiment where thegraft is not included.

In contrast to prior art self-expanding stents, the activelycontrollable stent deployment system 100 includes a stent lattice 110formed by interconnected lattice struts 112, 114. In this exemplaryembodiment, pairs of inner and outer struts 114, 112 are respectivelyconnected to adjacent pairs of inner and outer struts 114, 112. Moreparticularly, each pair of inner and outer struts 114, 112 are connectedpivotally at a center point of each strut 114, 112. The ends of eachinner strut 114 of a pair is connected pivotally to ends of adjacentouter struts 112 and the ends of each outer strut 112 of a pair isconnected pivotally to ends of adjacent inner struts 114. In such aconfiguration where a number of strut pairs 114, 112 are connected toform a circle, as shown in each of FIGS. 1 to 19, a force that tends toexpand the lattice 110 radially outward will pivot the struts 114, 112at each pivot point and equally and smoothly expand the entire lattice110 from a closed state (see, e.g., FIG. 3) to any number of open states(see FIGS. 4 to 13). Similarly, when the stent lattice 110 is at an openstate, a force that tends to contract the stent lattice 110 radiallyinward will pivot the struts 114, 112 at each pivot point and equallyand smoothly contract the entire stent lattice 110 towards the closedstate. This exemplary configuration, therefore, defines a repeating setof one intermediate and two outer pivot points about the circumferenceof the stent lattice 110. The single intermediate pivot point 210 is, inthe exemplary embodiment shown in FIGS. 1 to 19, located at the centerpoint of each strut 112, 114. On either side of the single intermediatepivot point 210 is a vertically opposing pair of outer pivot points 220.

To provide such expansion and contraction forces, the activelycontrollable stent deployment system 100 includes at least one jackassembly 700 that is present in each of FIGS. 1 to 19 but is described,first, with regard to FIG. 7. Each jack assembly 700 has a distal driveblock 710, a proximal drive block 720, and a disconnector drive block730. A drive screw 740 connects the distal drive block 710 to theproximal drive block 720. The drive screw 740 has a distal threadeddrive portion 742 having corresponding threads to a threaded drive bore712 of the distal drive block 710. The drive screw 740 has anintermediate unthreaded portion 744 that rotates freely within a smoothdrive bore 722 of the proximal drive block 720. In the embodiment shown,the inner diameter of the smooth drive bore 722 is slightly larger thanthe outer diameter of the unthreaded portion 744 so that the unthreadedportion 744 can freely rotate within the smooth drive bore 722substantially without friction. As used here, and in any of the otherexemplary embodiments, substantially without friction means that thedrive screw 740 can be turned when intended by a drive screw motor (asexplained below) but does not turn when the lattice is disconnected fromthe drive motor. This characteristic is a result of having the leadangle of the thread on the drive screw 740 be very small, for example,between approximately 1 and approximately 10 degrees, in particular,between approximately 3 and approximately 7 degrees, further, betweenapproximately 4 and approximately 5 degrees. This low angle makesturning the drive screw 740 to impart motion as described herein veryeasy but back-driving the screw almost impossible without damaging thedrive screw 740. Based upon this attribute, the stent lattice (and otherstent lattices described herein) become self-locking. The drive screw740 also has an intermediate collar 746 just proximal of the proximaldrive block 720. The outer diameter of the intermediate collar 746 isgreater than the inner diameter of the smooth drive bore 722. Lastly,the drive screw 740 has a proximal key portion 748 extending from theintermediate collar 746 in a proximal direction. The jack assembly 700is configured to retain the drive screw 740 within the distal driveblock 710 and the proximal drive block 720 in every orientation of thestent lattice 110, from the closed state, shown in FIG. 3, to a fullyopen state, shown in FIG. 11, where the distal drive block 710 and theproximal drive block 720 touch one another.

Each jack assembly 700 is attached fixedly to the stent lattice 110 at acircumferential location thereon corresponding to the verticallyopposing pair of outer pivot points 220. In one exemplary embodiment ofthe jack assembly 700 shown in FIGS. 1 to 19, the outer surface 714 ofthe distal drive block 710 and the outer surface 724 of the proximaldrive block 720 each have a protruding boss 716, 726 having an outershape that is able to fixedly connect to a respective one of the outerpivot points 220 of the stent lattice 110 but also rotationally freelyconnect thereto so that each of the inner and outer struts 114, 112connected to the boss 716, 726 pivots about the boss 716, 726,respectively. In this exemplary embodiment, each boss 716, 726 is asmooth cylinder and each outer pivot point 220 is a cylindrical borehaving a diameter corresponding to the outer smooth surface of thecylinder but large enough to pivot thereon without substantial friction.The materials of the boss 716, 726 and the outer pivot points 220 of theinner and outer struts 114, 112 can be selected to have substantiallyfrictionless pivoting.

Accordingly, as the drive screw 740 rotates between the open and closedstates, the unthreaded portion 744 of the drive screw 740 remainslongitudinally stable within the proximal drive block 720. In contrast,the distal threaded drive portion 742 progressively enters the threadeddrive bore 712 from the proximal end to the distal end thereof as thestent lattice 110 expands outwardly. As shown in the progressions ofFIG. 2 to FIG. 4 and FIGS. 5 to 7 to 8 to 9, as the drive screw 740rotates within the proximal drive block 720, the distal drive block 710moves closer and closer to the proximal drive block 720, thereby causinga radial expansion of the stent lattice 110.

To implant the stent lattice 110 in a tubular anatomic structure (suchas a vessel or a valve seat), the stent lattice 110 needs to bedisconnected from the delivery system. Delivery of the stent lattice 110to the anatomic structure will be described in further detail below.When the stent lattice 110 enters the implantation site, it will be mostlikely be in the closed state shown in FIG. 3, although for variousreasons, the stent lattice 110 can be expanded partially, if desired,before reaching the implantation site. For purposes of explaining thedisconnect, the extent of expansion is not relevant. When at theimplantation site, the stent lattice 110 will be expanded by rotatingthe drive screw 740 in a corresponding expansion direction (thedirection of threads of the drive screw 740 and the drive bore 712 willdetermine if the drive screw 740 needs to be rotated clockwise orcounter-clockwise). The stent lattice 110 is expanded to a desiredexpansion diameter, for example as shown in the progression of FIGS. 4to 9 or FIGS. 10 to 11, so that it accommodates to the natural geometryof the implantation site, even if the geometry is non-circular orirregular. When the implantation diameter is reached, e.g., in FIGS. 9and 11, the jack assemblies 700 need to be disconnected from theremainder of the stent deployment system 100.

To accomplish disconnect of the jack assemblies 700, the disconnectordrive block 730 is provided with two lumens. A first lumen, the drivelumen 732, accommodates a drive wire 750 that is able to rotationallyengage the proximal key portion 748. Use of the word wire for the drivewire 750 does not mean that this structure is a solid cord. The drivewire 750 can also be a hollow tube, a coil, or any other structure thatcan perform the functions described herein. In the exemplary embodimentshown, which is most clearly illustrated in FIG. 19, the proximal keyportion 748 has a square cross-sectional shape. A drive wire bushing 734rotationally freely but longitudinally fixedly resides in the drivelumen 732. The drive wire bushing 734 is connected to the drive wire 750either as an integral part thereof or through a connection sleeve 752.Regardless of the connection design, any rotation of the drive wire 750in either direction will cause a corresponding rotation of the drivewire bushing 734. A key hole 738 at the distal end of the disconnectordrive block 730 and having an internal shape corresponding to across-section of the proximal key portion 748 allows a rotationallyfixed but longitudinally free connection to occur with the proximal keyportion 748. In the exemplary embodiment shown in FIG. 19, the key hole738 also has a square cross-sectional shape.

The disconnector drive block 730 also has a second lumen, a disconnectlumen 731, which is best shown in FIGS. 14 and 16. Residing in thedisconnect lumen 731 in a rotationally free but longitudinally fixedmanner is a retainer screw 760. The retainer screw 760 has a distalthreaded portion 762, an intermediate shaft 764, and a proximalconnector 766. The distal threaded portion 762 has an exterior threadcorresponding to an internal thread of a connect lumen 1631, which islocated in the proximal drive block 720 and is coaxial with thedisconnect lumen 731. The intermediate shaft 764 has a smooth exteriorsurface and a cross-sectional shape that is slightly smaller than thecross-sectional shape of the disconnect lumen 731 so that it can berotated freely within the disconnect lumen 731 substantially withoutfriction (as above, this turns with the controlling motor but remainsfixed when disconnected, i.e., it is self-locking). The proximalconnector 766 has a flange with an outer diameter greater than the innerdiameter of the disconnect lumen 731. The proximal connector 766 isconnected at a proximal end thereof to a disconnect wire 770, whichconnection can either be an integral part thereof or through a secondaryconnection, such as a weld or connection sleeve. Use of the word wirefor the disconnect wire 770 does not mean that this structure is a solidcord. The disconnect wire 770 can also be a hollow tube, a coil, or anyother structure that can perform the functions described herein.

With such a configuration of the proximal drive block 720 and thedisconnector drive block 730 of a jack assembly 700, rotation in asecuring direction will longitudinally secure the proximal drive block720 to the disconnector drive block 730 so that the stent lattice 110remains connected to the drive wire 750 and the disconnect wire 770. Inthe connected state, the stent lattice 110 may be extended outward andretracted inward as many times as needed until implantation alignmentoccurs according to the surgeon's desire. Likewise, rotation in adisconnecting direction will longitudinally release the proximal driveblock 720 from the disconnector drive block 730 so that the stentlattice 110 disconnects entirely from the drive wire 750 and thedisconnect wire 770.

This process is illustrated with regard to FIGS. 10 to 19. In theexemplary illustration of FIG. 10, the stent lattice 110 is not fullyexpanded. Because the distal threaded portion 762 of the retainer screw760 is threaded within the connect lumen 1631 of the proximal driveblock 720, the disconnector drive block 730 remains longitudinally fixedto the proximal drive block 720—ideally, a configuration that existsfrom the time that the stent deployment system 100 first enters thepatient and at least up until implantation of the stent lattice 110occurs. Expansion of the stent lattice 110 is finished in theconfiguration of FIG. 11 and, for purposes of this example, it isassumed that the stent lattice 110 is correctly implanted at theimplantation site. Therefore, disconnection of the delivery system canoccur. It is noted that this implantation position just happens to be ata circumferential extreme of the stent lattice 110 because the distaldrive block 710 and the proximal drive block 720 are touching. In actualuse, however, it is envisioned that such touching does not occur whenexpanded for implantation and, in such a state, there is a separationdistance between the distal drive block 710 and the proximal drive block720 to give the stent lattice 110 room to expand further into theimplantation site if needed. Disconnection of the stent lattice 110begins by rotating the disconnect wire 770 in a direction that unscrewsthe threaded portion 762 of the retainer screw 760 from the connectlumen 1631. As the stent lattice 110 is implanted with expansive forceat the implantation site, the disconnector drive block 730 movesproximally as unthreading occurs. Complete unthreading of the retainerscrew 760 is shown in FIGS. 12 and 14. In a configuration with more thanone jack assembly 700 (the configuration of FIGS. 1 to 19 has 4, forexample), each disconnect wire 770, 770′ will rotate synchronously tohave each disconnector drive block 730 disconnect from its respectiveproximal drive block 720 substantially simultaneously, as shown in FIG.12. Such synchronous movement will be described in greater detail below.With the stent lattice 110 implanted, as shown in FIGS. 13, 15, 18, and19, the delivery system for the stent lattice 110 can be withdrawnproximally away from the implantation site and be retracted out from thepatient.

It is noted that the exemplary embodiment of FIGS. 1 to 19 shows theactively controllable stent deployment system 100 as having four jackassemblies 700 equally spaced around the circumference of the lattice110. This configuration is merely exemplary and any number of jackassemblies 700 can be used to expand and contract the lattice 110,including a minimum of one jack assembly 700 in total and a maximum ofone jack assembly 700 for each intersection between each inner and outerstrut pair 112, 114. Herein, three and four jack assemblies 700 aredepicted and used to show particularly well performing configurations.By using an even number, counter-rotating screws can be used to null thetorque.

FIG. 20 is provided to further explain how the stent lattice 110 moveswhen it is expanded and contracted. As set forth above, the activelycontrollable stent deployment system 100 is based upon the constructionof the stent lattice 110 and the attachment of the proximal and distaldrive blocks 720, 710 of at least one jack assembly 700 to at least oneset of the vertically opposing upper and lower pivot points 220 of thestent lattice 110. With the exemplary connections 716, 726 and pivotpoints 210, 220 shown in FIGS. 1 to 19, a longitudinal vertical movementof one of the proximal or distal drive blocks 720, 710 with respect tothe other will expand or contract the stent lattice 110 as describedherein. FIG. 20 illustrates with solid cylinders 2000 a radial path oftravel that each intermediate pivot point 210 will traverse as the stentlattice 110 is moved between its expanded state (e.g., FIG. 9) and itscontracted state (e.g., FIG. 2). Because the travel path is linear, thestent lattice 110 expands and contracts smoothly and equally throughoutits circumference.

It is noted that the struts 112, 114 shown in FIGS. 1 to 19 appear tonot be linear in certain figures. Examples of such non-linearity are thestruts in FIGS. 10 and 11. Therein, each strut 112, 114 appears to betorqued about the center pivot point such that one end is rotatedcounter-clockwise and the other is rotated clockwise. This non-linearitycan create the hourglass figure that will help fix the graft into animplantation annulus and to create a satisfactory seal at the top edgeof the implant. The non-linear illustrations are merely limitations ofthe computer design software used to create the various figures of thedrawings. Such non-linear depictions should not be construed asrequiring the various exemplary embodiments to have the rotation be apart of the inventive struts or strut configuration. Whether or not thevarious struts 112, 114 will bend, and in what way they will bend, isdependent upon the characteristics of the material that is used to formthe struts 112, 114 and upon how the pivot joints of the lattice 110 arecreated or formed. The exemplary materials forming the struts 112, 114and the pivots and methods for creating the pivots are described infurther detail below. For example, they can be stamped, machined, coinedor similar from the family of stainless steels and cobalt chromes.

With the invention, force is applied actively for the controlledexpansion of the stent lattice 110. It may be desirable to supplementthe outwardly radial implantation force imposed on the wall at which thestent lattice 110 is implanted. Prior art stent grafts have includedbarbs and other similar devices for supplementing the outward forces atthe implantation site. Such devices provide a mechanical structure(s)that impinge(s) on and/or protrude(s) into the wall of the implantationsite and, thereby, prevent migration of the implanted device. Thesystems and methods of the invention include novel ways forsupplementing the actively applied outward expansion force. Oneexemplary embodiment includes actively controllable needles, which isdescribed, first, with reference to FIG. 17. In this exemplaryembodiment, the distal drive block 710 and the proximal drive block 720contain a third lumen, a distal needle lumen 1711 and a proximal needlelumen 1721. Contained within both of the distal and proximal needlelumens 1711, 1721 is a needle 1700. In an exemplary embodiment, theneedle 1700 is made of a shape memory material, such as Nitinol, forexample. The needle 1700 is preset into a shape that is, for example,shown in the upper left of FIG. 12 (or it can form a majority or anentirety of a closed circle). A portion that remains in the distal andproximal needle lumens 1711, 1721 after implantation of the stentlattice 110 can be preset into a straight shape that is shown in FIG.17. A tissue-engaging distal portion of the needle 1700, however, isformed at least with a curve that, when extended out of the distal driveblock 710, protrudes radially outward from the center longitudinal axisof the stent lattice 110. In such a configuration, as the needle 1700extends outward, it drives away from the outer circumferential surface714 (see FIG. 5) of the distal drive block 710 (i.e., towards the viewerout from the plane shown in FIG. 5). The needle 1700 also has alongitudinal extent that places the distal tip 1210 within the distalneedle lumen 1711 when the stent lattice 110 is in the closed state,e.g., shown in FIG. 2.

Deployment of the needles 1700 in each jack assembly 700 (or the numberof needles can be any number less than the number of jack assemblies700) is illustrated, for example, starting with FIG. 5. In this example,the needles 1700 in each of the four jack assemblies 700 has a lengththat is shorter than the longitudinal end-to-end distance of theproximal and distal drive blocks 720, 710 because the needles 1700 havenot yet protruded from the distal upper surface 612 of each distal driveblock 710 even though the stent lattice 110 is partially expanded. Whenthe stent lattice 110 has expanded slightly further, however, as shownin FIG. 7, the needles 1700 begin protruding from the distal uppersurface 612. As the needles 1700 are pre-bent as set forth above, theneedles 1700 immediately begin bending into the natural pre-set curvedshape. See also FIGS. 7 and 8. FIG. 10 illustrates two needles 1700 evenfurther extended out from the distal needle lumen 1711 (only two areshown because this is a cross-section showing only the rear half of thestent lattice 110). FIG. 11 illustrates two needles 1700 in a fullyextended position (as the distal and proximal drive blocks 710, 720touch one another in the most-expanded state of the stent lattice 110).FIGS. 9, 13, 16, 17, 18, and 21 also show the needles 1700 in anextended or fully extended state.

How the needles 1700 each extend from the distal drive block 710 can beexplained in a first exemplary embodiment with reference to FIG. 17. Aproximal portion of the needle 1700 is connected fixedly inside theproximal needle lumen 1721. This can be done by any measure, forexample, by laser welding. In contrast, the intermediate and distalportions of the needle 1700 is allowed to entirely freely slide withinthe distal needle lumen 1711. With the length set as described above,when the distal and proximal drive blocks 710, 720 are separatedcompletely, as shown in FIG. 3, the needle 1700 resides in both distaland proximal needle lumens 1711, 1721. As one of the distal and proximaldrive blocks 710, 720 begins to move towards the other (as set forthabove, the exemplary embodiment described with regard to these figureshas the distal drive block 710 move towards the proximal drive block720), the proximal portion of the needle 1700 remains in the proximalneedle lumen 1721 but the distal portion of the needle 1700 begins toexit the distal upper surface 612, which occurs because the intermediateand distal portions of the needle 1700 are disposed slidably in thedistal needle lumen 1711. This embodiment where the proximal portion ofthe needle 1700 is fixed in the proximal needle lumen 1721 is referredto herein as dependent control of the needles 1700. In other words,extension of the needles 1700 out from the distal needle lumen 1711occurs dependent upon the relative motion of the distal and proximaldrive blocks 710, 720.

Alternatively, the supplemental retention of the stent lattice 110 atthe implantation site can occur with independent control of the needles.FIGS. 21 to 29 illustrate such an exemplary embodiment of a system andmethod according to the invention. Where similar parts exist in thisembodiment to the dependently controlled needles 1700, like referencenumerals are used. The jack assembly 2100 is comprised of a distal driveblock 710, a proximal drive block 720, a disconnector drive block 730, adrive screw 740, a drive wire 750 (shown diagrammatically with a dashedline), a retainer screw 760, and a disconnect wire 770. Different fromthe jack assembly 700 of FIGS. 1 to 19, the jack assembly 2100 alsoincludes a needle 2200 and a needle pusher 2210 and both the proximaldrive block 720 and the disconnector drive block 730 each define aco-axial third lumen therein to accommodate the needle pusher 2210. Morespecifically, the distal drive block 710 includes a first pusher lumen2211, the proximal drive block 720 includes a second pusher lumen 2221and the disconnector drive block 730 includes a third pusher lumen 2231.As described above, the retainer screw 760 keeps the proximal driveblock 720 and the disconnector drive block 730 longitudinally groundedto one another up until and after implantation of the stent lattice 110and separation of the delivery system occurs. Rotation of the drivescrew 740 causes the distal drive block 710 to move towards the proximaldrive block 720, thereby expanding the stent lattice 110 to the desiredimplantation diameter. This movement is shown in the transition betweenFIG. 22 and FIG. 23. Now that the stent lattice 110 is determined to beproperly implanted within the implantation site, it is time to deploythe needles 2200. Deployment starts by advancing the needle pusher 2180as shown in FIG. 24. The needle pusher 2810 can, itself, be the controlwire for advancing and retracting the needle 2200. Alternatively, and/oradditionally, a needle control wire 2182 can be attached to or shroudthe needle pusher 2180 to provide adequate support for the needle pusher2180 to function. Continued distal movement of the needle pusher 2180causes the needle 2200 to extend out from the distal upper surface 612and, due to the preset curvature of the memory-shaped needle 2200, theneedle tip curves outward and into the tissue of the implantation site.This curvature is not illustrated in FIG. 25 because the curvatureprojects out of the plane of FIG. 25.

Now that the stent lattice 110 is implanted and the needles 2200 areextended, disconnection of the stent lattice 110 occurs. First, as shownin FIG. 26, the retainer screw 760 is rotated to disconnect the proximaldrive block 720 from the disconnector drive block 730 and a proximallydirected force is imparted onto one or both of the drive wire 750 andthe disconnect wire 770. This force moves the disconnector drive block730 distally to remove the proximal key portion 748 of the drive screw740 out from the keyhole 738, as shown in the progression from FIGS. 26to 27. Simultaneously, distal movement of the disconnector drive block730 starts the withdrawal of the needle pusher 2180 from the firstpusher lumen 2211 (if not retracted earlier). Continued distal movementof the disconnector drive block 730 entirely removes the needle pusher2180 from the first pusher lumen 2211, as shown in FIG. 28. Finally,withdrawal of the stent lattice delivery system entirely from theimplantation site removes the needle pusher 2180 out from the secondpusher lumen 2221 leaving only the implanted stent lattice 110, the jackassembly(ies) 2100, and the needle(s) 2200 at the implantation site.

FIGS. 30 to 37 illustrate another exemplary embodiment of an independentneedle deployment system and method according to the invention. Wheresimilar parts exist in this embodiment to the embodiments describedabove, like reference numerals are used. The jack assembly 3000 iscomprised of a distal drive block 3010, a proximal drive block 3020, adisconnector drive block 3030, a drive screw 3040, a drive wire 750, aretainer screw 760, and a disconnect wire 770. The jack assembly 3000also includes a needle 3070 and a needle movement sub-assembly 3090. Theneedle movement sub-assembly 3090 is comprises of a needle support 3092,a needle base 3094, a needle disconnect nut 3096, and a needledisconnect wire 3098.

The distal drive block 3010 defines three longitudinal lumens. The firstis a support rod lumen 3012 and is defined to slidably retain a supportrod 3080 therein. As rotational torque is imparted when any screwassociated with the jack assembly 3000 rotates, the support rod 3080 isemployed to minimize and/or prevent such torque from rotating the distaland proximal drive blocks 3010, 3020 and disconnector drive block 3030with respect to one another and, thereby, impose undesirable forces onthe stent lattice 110. The longitudinal length of the support rod 3080is selected to not protrude out from the distal upper surface 3011 ofthe distal drive block 3010 in any expansion or retracted state of thestent lattice 110. The second vertically longitudinal lumen is the drivescrew lumen 3014. As in previous embodiments, the drive screw lumen 3014is configured with internal threads corresponding to external threads ofthe drive screw 740 and the longitudinal vertical length of the drivescrew lumen 3014 is selected to have the drive screw 740 not protrudeout from the distal upper surface 3011 of the distal drive block 3010 inany expansion or retracted state of the stent lattice 110. Finally, thedistal drive block 3010 defines a needle assembly lumen that iscomprises of a relatively wider proximal needle lumen 3016 and arelatively narrower distal needle lumen 3018, both of which will bedescribed in greater detail below.

In comparison to other proximal drive blocks described above, theproximal drive block 3020 of jack assembly 3000 defines two verticallylongitudinal lumens. The first lumen is a drive screw lumen 3024. Inthis exemplary embodiment, the drive screw 740 is longitudinally fixedlyconnected to the proximal drive block 3020 but is rotationally freelyconnected thereto. To effect this connection, a distal drive screwcoupler part 3052 is fixedly secured to the proximal end of the drivescrew 740 within a central bore that is part of the drive screw lumen3024 of the proximal drive block 3020. The distal drive screw couplerpart 3052 is shaped to be able to spin along its vertical longitudinalaxis (coaxial with the vertical longitudinal axis of the drive screw740) freely within the central bore of the drive screw lumen 3024. Adistal portion of the drive screw lumen 3024 is necked down to have adiameter just large enough to allow a portion of the drive screw 740(e.g., non-threaded) to spin therewithin substantially without friction.Through a circular port 3100 in a side of the proximal drive block 3020,the distal drive screw coupler part 3052 can be, for example,spot-welded to the proximal non-threaded end of the drive screw 740.With such a connection, the drive screw 740 is longitudinally fixedlygrounded to the proximal drive block 3020 within the central bore of thedrive screw lumen 3024. This means that rotation of the drive screw 740causes the distal drive block 3010 to move towards the proximal driveblock 3020 and, thereby, cause an expansion of the stent lattice 110connected to the jack assembly 3000, for example, at bosses 3600 shownin FIG. 36. Fasteners 3610 in the form of washers, rivet heads, orwelds, for example, can hold the stent lattice 110 to the bosses 3600.Further expansion of the drive screw coupler 3052, 3054 is made belowwith regard to the disconnector drive block 3030.

The second lumen within the proximal drive block 3020 of jack assembly3000 is a retainer screw lumen 3022. A distal portion of the retainerscrew lumen 3022 is shaped to fixedly hold a proximal end of the supportrod 3080 therein; in other words, the support rod 3080 is fastened atthe distal portion of the retainer screw lumen 3022 and moves only withmovement of the proximal drive block 3020. Fastening can occur by anymeasures, for example, by corresponding threads, welding, press fitting,or with adhesives. A proximal portion of the retainer screw lumen 3022has interior threads corresponding to exterior threads of the retainerscrew 760. Accordingly, disconnection of the disconnector drive block3030 from the proximal drive block 3020 is carried out by rotation ofthe retainer screw 760 fixedly connected to disconnector wire 770.Connection between the retainer screw 760 and the disconnector wire 770can be accomplished by any measures, including for example, a hollowcoupler sheath fixedly connected to both the distal end of thedisconnector coupler wire 770 and the proximal end of the retainer screw760 as shown in FIG. 30. As described above, the retainer screw 760keeps the proximal drive block 3020 and the disconnector drive block3030 longitudinally grounded to one another until after implantation ofthe stent lattice 110 and separation of the delivery system occurs.

This exemplary embodiment also has an alternative to the device andmethod for uncoupling the drive screw 740 from the remainder of the jackassembly 3000, in particular, the two-part drive screw coupler 3052,3054. The distal drive screw coupler part 3052 as, at its proximal end,a mechanical coupler that is, in this exemplary embodiment, asemicircular boss extending in the proximal direction away from thedrive screw 740. The proximal drive screw coupler part 3054, has acorresponding semicircular boss extending in the distal directiontowards the drive screw 740. These can be seen, in particular, in theenlarged view of FIG. 37. Therefore, when the two semicircular bossesare allowed to interconnect, any rotation of the proximal drive screwcoupler part 3054 will cause a corresponding rotation of the distaldrive screw coupler part 3052. The disconnector drive block 3030 has ascrew coupler bore 3031 shaped to retain the distal drive screw couplerpart 3052 therein. As in the proximal drive block 3020, the screwcoupler bore 3031 is shaped to surround the proximal drive screw couplerpart 3054 and allow the proximal drive screw coupler part 3054 to rotatefreely therewithin substantially without friction. A proximal portion ofthe screw coupler bore 3031 is necked down to a smaller diameter toprevent removal of the proximal drive screw coupler part 3054 after itis fixedly connected to the drive wire 750 either directly or through,for example, a hollow coupler as shown in FIGS. 30 to 37.

Implantation of the stent lattice 110 with the jack assembly 3000 isdescribed with regard to FIGS. 30 through 35. First, rotation of thedrive screw 740 causes the distal drive block 3010 to move towards theproximal drive block 3020, thereby expanding the stent lattice 110 tothe desired implantation diameter. This movement is shown in thetransition between FIG. 30 and FIG. 31. Now that the stent lattice 110is properly within the implantation site, deployment of the needles 3070can occur. Deployment starts by advancing the needle sub-assembly 3090as shown in the transition between FIGS. 31 and 32. Continued distalmovement of the needle subassembly 3090 causes the needle 3070 to extendout from the distal upper surface 3011 and, due to the preset curvatureof the memory-shaped needle 3070, the tip of the needle 3070 curvesoutward and into the tissue of the implantation site. This curvature isnot illustrated in FIGS. 32 and 33 because the curvature projects out ofthe plane of these figures.

In comparison to previous proximal drive blocks above, the disconnectordrive block 3030 does not have a lumen associated with the needle 3070.Only distal drive block 3010 has a lumen therein to accommodate theneedle 3070. More specifically, the distal drive block 3010 includes adistal needle lumen 3018 and a proximal needle lumen 3016. The distalneedle lumen 3018 is shaped to accommodate the needle 3070 only. Incontrast to other needle lumens, however, the proximal needle lumen 3016is non-circular in cross-section and, in the exemplary embodiment, isovular in cross-section. This shape occurs because the memory-shapedneedle 3070 is supported on its side along its proximal extent by aneedle support 3092, which is fastened side-to-side, for example, bywelding. The needle support 3092 has a relatively higher columnarstrength than the needle 3070 and, therefore, when fixedly connected tothe side of the needle 3070, the needle support 3092 significantlyincreases the connection strength to the needle 3070 at its side than ifthe needle 3070 was controlled only from the very proximal end thereof.A high-strength, exterior threaded needle base 3094 is fixedly attachedto the proximal end of the needle support 3092. This configuration alsokeeps the needle clocked properly so that its bend direction is awayfrom the center of the lattice and most directly attaches to the vesselwall.

Control of the needle 3070 is, as above, carried out by a needledisconnect wire 3098 (depicted with dashed lines). Attached to thedistal end of the disconnect wire 3098 is a needle disconnect nut 3096defining a distal bore with interior threads corresponding to theexterior threads of the needle base 3094. In this configuration,therefore, rotation of the needle disconnect wire 3098 causes the needledisconnect nut 3096 to either secure to the needle base 3094 or removefrom the needle base 3094 so that disconnection of the delivery systemfrom the stent lattice 110 can occur. The top side of the distal driveblock 3010 is cross-sectioned in FIG. 36 at the boss 3600 to show theshapes of the various lumens therein. As described above, the supportrod lumen 3012 is a smooth, circular-cross-sectional bore to allow thesupport rod 3080 to slide longitudinally vertically therein. Similarly,the distal-portion of the drive screw lumen 3014 is also a smooth,circular-cross-sectional bore to allow the drive screw 740 to movelongitudinally vertically therein as it is rotated and the threadsengage the proximal threaded portion of the drive screw lumen 3014. Theproximal needle lumen 3016, in contrast, is non circular (e.g., ovular)to accommodate the cylindrical-shaped needle 3070 and theside-by-side-connected, cylindrical-shaped, needle support 3092. Asshown in the view of FIG. 36, at least the contacting portion of theneedle 3070 to the needle support 3092 is shrouded with a connectorsleeve 3071, which has material properties that allow it to be fixedlyconnected to the needle 3070 and, at the same time, to the needlesupport 3092.

Extension of the needle 3070 out from the distal upper surface 3011 bythe distal movement of the disconnect wire 3098 is illustrated by thetransition from FIG. 31 to FIG. 32. Only a small portion of the needle3070 extends from the distal upper surface 3011 because the views ofFIGS. 30 to 33 are vertical cross-sections along a curved intermediateplane shown, diagrammatically, with dashed line X-X in FIG. 36. As theneedle 3070 extends in front of this sectional plane, it is cut off inthese figures. FIGS. 34 and 35, however clearly show the extended needle3070 curving out and away from the outer side surface 3415, however,merely for clarity purposes, the needle 3070 is rotated on itslongitudinal axis slightly to the right so that it can be seen in FIG.34 and seen better in FIG. 35. It is note that another exemplaryembodiment of the needle 3070 includes a hooked or bent needle tip 3072.Correspondingly, the distal drive block 3010 includes a needle tipgroove 3013 to catch the bent needle tip 3072 and utilize it in a way tokeep tension on the needle 3070 and the needle disconnect wire 3098. Thebend in the needle tip 3072 also allows the needle 3070 to penetrateearlier and deeper than without such a bend. Another advantage forhaving this bend is that it requires more load to straighten out the tipbend than the overall memory shape of the needle and, thereby, it keepsthe needle located distally in the jack assembly 3000. If sufficientspace exists in the distal drive block, a plurality of needles (e.g., aforked tongue) could be used.

Removal of the delivery system is described with regard to FIGS. 32, 33,and 37 after the stent lattice 110 is implanted and the needle 3070 ofeach jack assembly 3000 is extended. The retainer screw 760 keeps theproximal drive block 3020 and the disconnector drive block 3030longitudinally grounded to one another up until implantation of thestent lattice 110 and extension of the needles 3070 (if needles 3070 areincluded). Separation of the delivery system begins by rotation of thedisconnector wire 770 to unscrew the retainer screw 760 from theretainer screw lumen 3022, which occurs as shown in the transition fromFIG. 32 to FIG. 33. Because the two parts of the drive screw coupler3052, 3054 are not longitudinally fastened to one another, the drivescrew coupler 3052, 3054 does not hinder disconnection of thedisconnector drive block 3030 in any way. Before, at the same time, orafter removal of the retainer screw 760 from the retainer screw lumen3022, the needle disconnect wire 3098 is rotated to, thereby,correspondingly rotate the needle disconnect nut 3096. After a number ofrotations, a needle disconnect nut 3096 is entirely unscrewed from thethreads of the needle base 3094, which is shown in FIG. 33, for example.The delivery system, including the disconnector drive block 3030, itscontrol wires (drive wire 750 and disconnect wire 770), and the needledisconnect wire 3098 and disconnect nut 3096, can now be removed fromthe implantation site.

Other exemplary embodiments of the stent lattice according to theinvention is shown with regard to FIGS. 38 to 50. In a first exemplaryembodiment, the stent lattice is a proximal stent 3810 of a stent graft3800. The proximal stent 3810 is connected to and covered on itsexterior circumferential surface with a graft 3820. With the proximalstent 3810 in a partially expanded state in FIG. 39 and other expandedstates in FIGS. 40 and 41, it can be seen that the outer struts 3812have at least one throughbore 3814, in particular, a line ofthroughbores from one end to the other, extending through the outerstrut 3812 in a radial direction. These throughbores allow the graft3820 to be sewn to the outer struts 3812.

As described above, it can be beneficial for stents to have barbs,hooks, or other measures that catch and do not release tissue when theycontact the tissue at or near an implantation site. FIGS. 42 to 45illustrate one exemplary embodiment of the invention. When constructingthe stent lattice 4200, attachment of the three pivot points makes eachouter strut 4230 curve about its center pivot point, as can be seen inthe lower right corner of FIG. 44, for example. Past the outer two pivotpoints of each outer strut 4230, however, there is no curve imparted.The invention takes advantage of this and provides extensions 4210 andbarbs 4220 on one or more ends of the outer struts 4230 because the lackof curvature at the ends of the outer strut 4230 means that the outerportion will extend outward from the circumferential outer surface ofthe stent lattice 4200. In the expanded configuration of the stentlattice 4200 shown in FIG. 42, it can be seen that the extensions 4210and barbs 4220 each project radially outward from the outercircumferential surface of the stent lattice 4200 and the points of thebarbs 4220 also point radially outward, even if at a shallow angle.

It is noted that each of the exemplary embodiments of the stent latticesillustrated above has the intermediate pivot point at the center pointof each strut. Having the intermediate pivot point in the center is onlyexemplary and can be moved away from the center of each strut. Forexample, as shown in FIGS. 46 to 50, the stent lattice 4600 can have theintermediate center pivot 4612 of the struts 4610 be closer to one end4614 than the other end 4616. When the center pivot 4612 is off-center,the side closer to the one end 4614 tilts inwards so that the outercircumferential surface of the stent lattice 4600 takes the shape of acone. FIGS. 48, 49, and 50 illustrate the conical stent lattice 4600expanded, partially expanded, and almost completely retracted,respectively.

The exemplary stent lattice embodiments in FIGS. 38 to 50 show the pivotpoints connected by screws. Any number of possible pivoting connectionscan be used at one or more or all of the pivot points. One exemplaryembodiment of a strut-connection assembly 5100 can be seen in FIGS. 51to 53. Because the stent lattice of the invention is intended to besmall and fit in very small anatomic sites (e.g., heart valve, aorta,and other blood vessels), it is desirable to have the lattice struts beas thin as possible (i.e., have a low profile). The profile of thescrews shown in FIGS. 38 to 50 can be reduced even further by theinventive strut-connection system 5100 as shown in FIGS. 51 to 53. FIG.51 illustrates one such low-profile connection, which is formed using arivet 5110 and forming the rivet bores in the each of the strut endswith one of a protrusion 5120 and an opposing indention (the latter notillustrated in FIG. 52). The rivet 5110 is formed with a low-profilerivet head 5112, an intermediate cylindrical boss 5114, and a slightlyoutwardly expanded distal end 5116 (see FIG. 53). By placing two of theends of the struts next to one another as shown in FIG. 52, with one ofthe protrusions 5120 placed inside the indention of the opposing strut,the two strut ends form a pivot that is able to slide about the centralpivot axis. The rivet 5110 is merely used to lock to strut ends againstone another by having the expanded distal end 5116 enter through one ofthe non-illustrated indention sides of the strut and exit through theprotrusion-side of the opposing strut. It is the features on the strutsthat form the pivot and not the features of the rivet 5110.

FIGS. 54 to 63 illustrate various alternative configurations of thestruts in stent lattices according to exemplary embodiments of theinvention. Each of the different lattice configurations providesdifferent characteristics. One issue that occurs with lattices havingalternating struts is that expansion and contraction of the adjacentstruts can adversely rub against the graft securing measures (e.g.,stitchings). With that consideration, the invention provides twoseparate cylindrical sub-lattices in the embodiment of FIGS. 54 to 57.Each of the crossing points of the interior and exterior sub-lattices isconnected via fasteners (e.g., rivets, screws, and the like). The outerends of the struts, however, are not directly connected and, instead,are connected by intermediate hinge plates having two throughboresthrough which a fastener connects respectively to each of the adjacentstrut ends. The intermediate hinge plates translate longitudinallytowards each other upon expansion of the stent lattice and never haveany portion of stent lattice pass in front or behind them. These hingeplates, therefore, could serve as connection points to the graft orcould connect to a band or a rod, the band serving to join the two hingeplates together and, thereby, further spread the expansion forces on thegraft. In an exemplary embodiment where the graft material has atransition zone where expansible material transitions to non-expansiblematerial (and back again if desired), such bands or rods could extendfurther past the longitudinal end of the lattice and provide anattachment or securing point for a non-expansible portion of the graftmaterial. In this configuration, as shown in FIG. 57, for example, ifgraft material is attached to the outer sub-lattice, then, there is nointerruption and the graft is not damaged with the struts acting asscissors. FIGS. 58 to 63 illustrate another exemplary embodiment of thestrut lattices according to the invention in which the inner sub-latticeis shorter in the longitudinally vertical direction than the outersub-lattice.

The exemplary actively controllable stent lattices of the invention canbe used in devices and methods in which prior art self-expanding stentshave been used. In addition to the example of a proximal stent shown inthe exemplary stent graft of FIGS. 38 to 41, the technology describedherein and shown in the instant stent delivery systems and methods fordelivering such devices can be use in any stent graft or implant, suchas those used in abdominal or thoracic aneurysm repair. Additionally,the exemplary stent lattices of the invention can be used in replacementheart valves, for example.

Referring now to the figures of the drawings in detail and first,particularly to FIGS. 64 to 70, there is shown a first exemplaryembodiment of an actively controllable aortic valve assembly and methodsand systems for controlling and implanting such devices. Even though theexemplary embodiment is shown for an aortic valve, the invention is notlimited thereto. The invention is equally applicable to pulmonary,mitral and tricuspid valves.

The inventive technology used, for example, with regard to aortic valverepair includes a replacement aortic valve assembly 6400 according tothe invention. One exemplary aortic valve assembly 6400 is depicted inFIGS. 64 and 65. FIG. 64 illustrates an adjustable lattice assembly 6410similar to that shown in FIG. 103. In particular, the lattice assembly6410 includes a number of struts 6412 crossing one another in pairs andpivotally connected to one another in an alternating manner at crossingpoints 6420 and end points 6422 of the struts 6412. Like the embodimentin FIG. 103, the lattice assembly 6410 is controlled, in this exemplaryembodiment, by a set of three jack assemblies 6430 each having aproximal drive block 6432, a distal drive block 6434, and a drive screw740 connecting the proximal and distal drive blocks 6432, 6434 together.In this exemplary embodiment, the drive screw 740 performs as above, itis longitudinally fixed but rotationally freely connected to the distaland proximal drive blocks 6432, 6434 such that, when rotated in onedirection, the distal and proximal drive blocks 6432, 6434 move awayfrom one another and, when rotated in the other direction, the distaland proximal drive blocks 6432, 6434 move towards one another. In such aconfiguration, the former movement radially contracts the latticeassembly 6410 and the latter movement expands the lattice assembly 6410.The lattice assembly 6410 shown in FIGS. 64 and 65 is in its expandedstate, ready for implantation such that it accommodates to the naturalgeometry of the implantation site. Connected at least to the three jackassemblies 6430 at an interior side of one or both of the distal andproximal drive blocks 6432, 6434 is an exemplary embodiment of athree-leaf valve assembly 6440 (e.g., an aortic valve assembly). Thevalve assembly 6440 can be made of any desired material and, in anexemplary configuration, is made of bovine pericardial tissue or latex.

An exemplary embodiment of a delivery system and method shown in FIGS.66 to 70 and disclosed herein can be used to percutaneously deploy theinventive aortic valve assembly 6440 in what is currently referred to asTranscatheter Aortic-Valve Implantation, known in the art under theacronym TAVI. As set forth above, this system and method can equally beused to deploy replacement pulmonary, mitral and tricuspid valves aswell. The configuration of the delivery system and the valve assembly6440 as an aortic valve assembly provide significant advantages over theprior art. As is known, current TAVI procedures have a risk of leakbetween an implanted device and the aortic valve annulus, referred to asparavalvular leak. Other disadvantages of prior art TAVI proceduresinclude both migration (partial movement) and embolism (completerelease). The reason for such movement is because, before use and entryinto the patient, the prior art replacement aortic valves are requiredto be crushed manually by the surgeon onto an interior balloon that willbe used to expand that valve again when ready for implantation. Becausethe native annulus of the implantation site is not circular, and due tothe fact that the balloon forces the implanted pre-crushed valve to takea final shape of the circular balloon, prior art implants do not conformto the native annulus. Not only are such prior art systems hard to use,they provide no possibility of repositioning the implanted valve oncethe balloon has expanded.

The progression of FIGS. 66 to 70 illustrates an exemplary implantationof the inventive aortic valve assembly 6440. Various features of thedelivery system are not illustrated in these figures for reasons ofclarity. Specifically, these figures show only the guidewire 6610 andthe nose cone 6620 of the delivery system. FIG. 66 shows the guidewire6610 already positioned and the aortic valve assembly 6440 in acollapsed state resting in the delivery system just distal of the nosecone 6620. In this illustration, the aortic valve assembly 6440 and nosecone 6620 are disposed in the right iliac artery. FIG. 67 depicts theaortic valve assembly 6440 and nose cone 6620 in an advanced position onthe guidewire 6610 within the abdominal aorta adjacent the renalarteries. FIG. 68 shows the aortic valve assembly 6440 just adjacent theaortic valve implantation site. Finally, FIGS. 69 and 70 show the aorticvalve assembly 6440 implanted in the heart before the nose cone 6620and/or the guidewire 6610 are retracted.

The inventive delivery system and aortic valve assembly 6440 eliminateeach of the disadvantageous features of the prior art. First, there isno need for the surgeon to manually crush the implanted prosthesis.Before the aortic valve assembly 6440 is inserted into the patient, thedelivery system simply reduces the circumference of the lattice 6410automatically and evenly to whatever diameter is desired by the surgeon,the delivery system requires, or is reduced in diameter by themanufacturer and loaded into the delivery system for later implantation.The stent and valve assemblies described herein can be reduced to aloading diameter of between 4 mm and 8 mm, and, in particular, 6 mm, tofit inside a 16-20 French sheath, in particular, an 18 French or smallerdelivery sheath. When the aortic valve assembly 6440 reaches theimplantation site, the surgeon causes the delivery system to evenly andautomatically expand the aortic valve assembly 6440. As this expansionis slow and even into the implant position, it is gentle oncalcification at the implant site. Likewise, the even expansion allowsthe lattice structure to assume the native, non-circular perimeter ofthe implant site not only due to the way the delivery system expands thelattice assembly 6410, but also because the hinged connections of eachof the struts 6412 allows the lattice assembly 6410 to bend and flexnaturally after implantation dependent upon the correspondingnon-uniform tissue wall adjacent to each pivoting strut 6412 (assumptionof the natural shape of the implantation wall also occurs with thealternative non-hinged embodiments disclosed herein). Due to thesefacts, a better seating of the implant occurs, which leads axiomaticallyto a better paravalvular seal. The inventive delivery system sizes theprosthesis precisely, instead of the gross adjustment and installationpresent in the prior art. Another significant disadvantage of the priorart is that a balloon is used within the central opening of the valve toexpand the valve, thus completely occluding the aorta and causingtremendous backpressure on the heart, which can be hazardous to thepatient. The valves described herein, in contrast, remain open duringdeployment to, thereby, allow continuous blood flow during initialdeployment and subsequent repositioning during the procedure and alsostart the process of acting as a valve even when the implant is notfully seated at the implantation site.

Significantly, prior art TAVI systems require a laborious sizing processthat requires the replacement valve to be sized directly to theparticular patient's annulus, which sizing is not absolutely correct.With the delivery system and aortic valve assemblies described herein,however, the need to size the valve assembly beforehand no longerexists—all that is needed is to select an implant having somewherewithin an intermediate position of the implant's expansion range theapproximate diameter of the annulus at the implantation site.Additionally, with regard to both stent graft and valve systemsdescribed herein, because the stent assemblies are adjustable, they canbe adjusted even after being implanted within a vessel for a long periodof time. For example, when conducting a TAVI process in children havingcongenital defects, there is a need to remove and implant a new valveafter a few years because of the patient's growth. The assembliesdescribed herein, in contrast to the prior art, can be re-docked wellafter implantation and further expanded, either at regular intervals orperiodically, to adjust for the patient's growth.

The aortic valve assembly 6440 is configured to have a valve leafoverlap 6542 (see FIG. 65) that is more than sufficient when the aorticvalve assembly 6440 is at its greatest diameter and, when the aorticvalve assembly 6440 is smaller than the greatest diameter, the valveleaf overlap 6542 merely increases accordingly. An exemplary range forthis overlap can be between approximately 1 mm and approximately 3 mm.

A further significant advantage not provided by prior art TAVI systemsis that the inventive delivery system and valve assembly can beexpanded, contracted, and re-positioned as many times operatively asdesired, but also the inventive delivery system and valve assembly canbe re-docked post-operatively and re-positioned as desired. Likewise,the learning curve for using the inventive delivery system and valveassembly is drastically reduced for the surgeon because an automaticcontrol handle (described in further detail below) performs eachoperation of extending, retracting, adjusting, tilting, expanding,and/or contracting at a mere touch of a button (see, e.g., FIGS. 105 to107).

Another exemplary use of the inventive lattice assembly and deliverysystem is for a latticework-actuated basket filter, which can be eitheradded to the devices, systems, and methods disclosed herein or which canstand-alone. Such an embolic umbrella can perform better than, forexample, the EMBOL-X® Glide Protection System produced by EdwardLifesciences. Such a filter would be attached to the docking jacks sothat it expands in place automatically as the device is expanded butwould be removed with the delivery system without any additional effortson the part of the surgeon.

Another exemplary embodiment of a replacement heart valve assembly 7100according to the invention is shown in FIGS. 71 to 83. Even though theexemplary embodiment is shown for an aortic valve, the invention is notlimited thereto. This embodiment is equally applicable to pulmonary,mitral and tricuspid valves with appropriate changes to the valveleaflets, for example. The replacement heart valve assembly 7100 shownin various views in FIGS. 71 to 75 is comprised of a stent lattice 7110,graft enclosures 7120, jack assemblies 3000, graft material 7130, valveleaflets 7140, and commisure plates 7150. Operation and construction ofthe replacement heart valve assembly 7100 is explained with reference toFIGS. 76 to 83 with various views therein having the graft material 7130and/or the valve leaflets 7140 removed. In FIGS. 75 and 76, thereplacement heart valve assembly 7100 is in an expanded state (when usedherein, “expanded state” does not mean that the state shown is thegreatest expanded state of the prosthesis; it means that the prosthesisis expanded sufficiently enough to be sized for an implantation in someanatomic site) such that it accommodates to the natural geometry of theimplantation site. With the graft material removed (see, e.g., FIG. 76),the structure around the three valve leaflets 7140 is easily viewed. Theproximal and distal drive blocks 3020, 3010 have internal configurationsand the support rod 3080, the drive screw 740, and the distal drivescrew coupler part 3052 disposed therein.

The stent lattice 7110 is similar to previous embodiments describedherein except for the center pivot points of each strut 7112 of thestent lattice 7110 and the graft enclosures 7120. In the exemplaryembodiment shown, the center pivot points are not merely pivotingconnections of two struts 7112 of the stent lattice 7110. In addition,the outer-most circumferential surface of the pivoting connectioncomprises a tissue anchor 7114, for example, in the form of a pointedcone in this exemplary embodiment. Other external tissue anchoringshapes are equally possible, including spikes, hooks, posts, andcolumns, to name a few. The exterior point of the tissue anchor 7114supplements the outward external force imposed by the actively expandedstent lattice 7110 by providing structures that insert into the adjacenttissue, thereby further inhibiting migration and embolism.

The graft enclosures 7120 also supplement the outward external forceimposed by the actively expanded stent lattice 7110 as explained below.A first characteristic of the graft enclosures 7120, however, is tosecure the graft material 7130 to the replacement heart valve assembly7100. The graft material 7130 needs to be very secure with respect tothe stent lattice 7110. If the graft material 7130 was attached, forexample, directly to the outer struts 7112 of the stent lattice 7110,the scissoring action that the adjacent struts 7112 perform as the stentlattice 7110 is expanded and contracted could adversely affect thesecurity of the graft material 7130 thereto—this is especially true ifthe graft material 730 was sewn to the outer struts 7112 and the threadpassed therethrough to the inside surface of the outer strut 7112,against which the outer surface of the inner strut 7112 scissors in use.Accordingly, the graft enclosures 7120 are provided at a plurality ofthe outer struts 7112 of the stent lattice 7110 as shown in FIGS. 71 to87. Each graft enclosure 7120 is fixedly attached at one end of its endsto a corresponding end of an outer strut 7112. Then, the opposing, freeend of the graft enclosure 7120 is woven through the inner side of thegraft material 7130 and then back from the outer side of the graftmaterial 7130 to the inner side thereof as shown in FIGS. 71 to 75, forexample. The opposing, free end of the graft enclosure 7120 is fixedlyattached to the other end of the outer strut 7112. This weaving reliablysecures the outer circumferential side of the graft material 7130 to thestent lattice 7110.

As mentioned above, graft enclosures 7120 simultaneously supplement theoutward external force imposed by the actively expanded stent lattice7110 with edges and protrusions that secure the replacement heart valveassembly 7100 at the implantation site. More specifically, the graftenclosures 7120 are not linear as are the exemplary embodiment of theouter struts 7112 of the stent lattice 7110. Instead, they are formedwith a central offset 7622, which can take any form and, in theseexemplary embodiments, are wave-shaped. This central offset 7622 firstallows the graft enclosure 7120 to not interfere with the tissue anchor7114. The central offset 7622 also raises the central portion of thegraft enclosure 7120 away from the stent lattice 7110, as can be seen,for example, to the right of FIGS. 76 and 77 and, in particular, in theviews of FIGS. 82 and 83. The radially outward protrusion of the centraloffset 7622 inserts and/or digs into adjacent implantation site tissueto, thereby, inhibit any migration or embolism of the replacement heartvalve assembly 7100. By shaping the central offset 7622 appropriately, ashelf 7624 is formed and provides a linear edge that traverses a lineperpendicular to the flow of blood within the replacement heart valveassembly 7100. In the exemplary embodiment of the central offset 7622shown in FIGS. 76, 77, and 79 to 81, the shelf 7624 is facing downstreamand, therefore, substantially inhibits migration of the replacementheart valve assembly 7100 in the downstream direction when exposed tosystolic pressure. Alternatively, the central offset 7622 can be shapedwith the shelf 7624 is facing upstream and, therefore, substantiallyinhibits migration of the replacement heart valve assembly 7100 in theupstream direction when exposed to diastolic pressure. The graftmaterial needs to be able to stay intimately attached to the latticethroughout a desired range of terminal implantable diameters. Toaccomplish this, the graft material is made from a structure of materialthat moves in a fashion like that of the lattice. That is to say, as itsdiameter increases, its length decreases. This kind of movement can beaccomplished with a braid of yarns or through the fabrication of graftmaterial where its smallest scale fibers are oriented similarly to abraid, allowing them to go through a scissoring action similar to thelattice. One exemplary embodiment of the material is a high end-countbraid made with polyester yarns (e.g., 288 ends using 40-120 denieryarn). This braid can, then, be coated with polyurethane, silicone, orsimilar materials to create stability and reduce permeability by joiningall the yarns together. These coatings can be doped or filled withradiopaque material to improve visibility under fluoroscopy. The amountof coating (polyurethane, for example) can be varied to be increasedwhere high-wear or trimming occurs. If the braid is trimmed bylaser-cutting, for example, the cutting process seals the cut edge toprevent fraying and allows for reduction or elimination of the need fora coating, such as polyurethane. Likewise, a spun-fiber tube can be madewith similar polymers forming strands from approximately 2-10 microns indiameter. These inventive graft fabrication methods provide for amaterial that will be about 0.005″ to 0.0015″ (0.127 mm to 0.381 mm)thick and have all the physical properties necessary. See, for example,FIGS. 195-199. A thin material is desirable to reduce the compacteddiameter for easier introduction into the patient. This material is alsoimportant in a stent graft prosthesis where the lattice is required toseal over a large range of possible terminal diameters. The adjustablematerial is able to make the transition from the final terminal diameterof the upstream cuff to the main body of the graft.

As best shown in FIG. 73, the valve leaflets 7140 are connected bycommisure plates 7150 to the jack assemblies 3000. Fixed connection ofthe commisure plates 7150 to the jack assemblies 3000 is best shown inFIGS. 82 and 83. Each valve leaflet 7140 is connected between twoadjacent commisure plates 7150. Each commisure plate 7150 is comprisesof two vertically disposed flat plates having rounded edges connected,for example, by pins projecting orthogonally to the flat plates.Pinching of the flat plates against the two adjacent valve leaflets 7140securely retains the valve leaflets 7140 therein while, at the sametime, does not form sharp edges that would tend to tear the capturedvalve leaflets 7140 therein during prolonged use. This configuration,however, is merely exemplary. This could be replaced with a simpler roddesign around which the leaflets are wrapped and stitched into place.

Even though each valve leaflet 7140 can be a structure separate from theother valve leaflets 7140, FIGS. 71 to 78 illustrate the three leaflets7140 as one piece of leaf-forming material pinched, respectively,between each of the three sets of commisure plates 7150 (the materialcan, alternatively, pinch around the commisure plate or plates). Theupstream end of the valve leaflets 7140 must be secured for thereplacement heart valve assembly 7100 to function. Therefore, in anexemplary embodiment, the upstream end of the graft material 7130 iswrapped around and fixedly connected to the replacement heart valveassembly 7100 at the upstream side of the valve leaflets 7140, as shownin FIG. 78. In such a configuration, the upstream edge of the valveleaflets 7140 is secured to the graft material 7130 entirely around thecircumference of the stent lattice 7110. Stitches can pass through thetwo layers of graft and the upstream edge of the leaflet material toform a hemmed edge.

FIGS. 79 to 81 show the stent lattice 7110 in various expanded andcontracted states with both the graft material 7130 and the valveleaflets 7140 removed. FIG. 79 illustrates the stent lattice 7110 andjack assemblies 3000 in an expanded state where the tissue anchor 7114and the central offset 7622 protrude radially out from the outercircumferential surface of the stent lattice 7110 such that the stentlattice 7110 accommodates to the natural geometry of the implantationsite. FIG. 80 illustrates the stent lattice 7110 and the jack assemblies3000 in an intermediate expanded state and FIG. 81 illustrates the stentlattice 7110 and the jack assemblies 3000 in a substantially contractedstate.

FIGS. 84 and 85 show an exemplary embodiment of a support system 8400 ofthe delivery system and method according to the invention for bothsupporting the jack assemblies 3000 and protecting the various controlwires 750, 770, 2182, 3098 of the jack assemblies 3000. In thesefigures, the support bands 8410 are shown as linear. This orientation ismerely due to the limitations of the computer drafting software used tocreate the figures. These support bands 8410 would only be linear asshown when unconnected to the remainder of the delivery system for thereplacement heart valve assembly 7100. When connected to the distal endof the delivery system, as diagrammatically shown, for example, in FIGS.1, 3, 4, and 9 with a wire-guide block 116, all control wires 750, 770,2182, 3098 will be directed inwardly and held thereby. Similarly, theproximal ends 8412 of the support bands 8410 will be secured to thewire-guide block 116 and, therefore, will bend radially inward. In theexemplary embodiment of the support bands 8410 shown in FIGS. 84 and 85,the distal ends 8414 thereof are fixedly secured to the disconnectordrive block 3030 by an exemplary hinge assembly 8416. In this exemplaryembodiment, therefore, the support bands 8410 are of a material andthickness that allows the delivery system to function. For example,while traveling towards the implantation site, the replacement heartvalve assembly 7100 will traverse through a curved architecture.Accordingly, the support bands 8410 will have to bend correspondingly tothe curved architecture while, at the same time, providing enoughsupport for the control wires 750, 770, 2182, 3098 to function in anyorientation or curvature of the delivery system.

An alternative exemplary connection assembly of the support bands 8610according to the invention is shown in FIGS. 86 and 87. The distal end8614 of each support band 8610 is connected to the disconnector driveblock 3030 by a hinge assembly 8416. The hinge assembly 8416, forexample, can be formed by a cylindrical fork at the distal end 8614 ofthe support band 8610, an axle (not illustrated), and a radiallyextending boss of the disconnector drive block 3030 defining an axlebore for the axle to connect the cylindrical fork to the boss. In such aconfiguration, the support bands 8610 can have different material orphysical properties than the support bands 8410 because bendingmovements are adjusted for with the hinge assembly 8416 instead of withthe bending of the support bands 8410 themselves. The proximal end ofthe support bands 8610 are not shown in either FIG. 86 or 87.Nonetheless, the proximal ends can be the same as the distal end of thesupport bands 8610 or can be like the distal end 8614 of the supportbands 8410. By pre-biasing the support bands to the outside, they canhelp reduce or eliminate the force required to deflect the controlwires.

An embodiment of the replacement heart valve assembly 7100 as an aorticvalve is shown implanted within the diseased valve leaflets of apatient's heart in FIG. 88. As can be seen in this figure, the naturalvalve takes up some room at the midline of the replacement heart valveassembly 7100. Therefore, the stent lattice of the replacement heartvalve assembly 7100 can be made to have a waistline, i.e., a narrowermidline, to an hourglass shape instead of the barrel shape. In such aconfiguration, the replacement heart valve assembly 7100 is naturallypositioned and held in place.

A further exemplary embodiment of the inventive actively controllablestent lattice and the delivery system and method for delivering thestent lattice are shown in FIGS. 89 to 93. In this embodiment, theprosthesis 8900 includes a stent lattice 110, 3810, 4200, 4600, 6410,7110 and three jack assemblies 700, 2100, 3000, 6430. These figures alsoillustrate a distal portion of an exemplary embodiment of a deliverysystem 8910 for the inventive prosthesis 8900. Shown with each jackassembly 700, 2100, 3000, 6430 are the drive and disconnect wires 750,700, which are illustrated as extending proximally from the respectivejack assembly 700, 2100, 3000, 6430 into a wire guide block 116. Due tothe limitations of the program generating the drawing figures, thesewires 750, 770 have angular bends when traversing from the respectivejack assembly 700, 2100, 3000, 6430 towards the wire guide block 116.These wires, however, do not have such angled bends in the invention.Instead, these wires 750, 770 form a gradual and flattened S-shape thatis illustrated diagrammatically in FIG. 89 with a dashed line 8920.Operation of the prosthesis 8900 is as described above in all respectsexcept for a tilting feature regarding the wires 750, 770. Specifically,rotation of the drive wire 750 in respective directions will contractand expand the stent lattice 110, 3810, 4200, 4600, 6410, 7110. Then,when the stent lattice 110, 3810, 4200, 4600, 6410, 7110 is implantedcorrectly in the desired anatomy, the disconnect wire 770 will berotated to uncouple the proximal disconnector drive block and, thereby,allow removal of the delivery system 8910. This embodiment provides thedelivery system 8910 with a prosthesis-tilting function. Morespecifically, in the non-illustrated handle portion of the deliverysystem 8910, each pair of drive and disconnect wires 750, 770 are ableto be longitudinally fixed to one another and, when all of the pairs arefixed respectively, each pair can be moved distally and/or proximally.

In such a configuration, therefore, if the wires 750, 770 labeled withthe letter X are moved proximally together and the other two pairs ofwires Y and Z are moved distally, then the entire prosthesis 8900 willtilt into the configuration shown in FIG. 90. Alternatively, if thewires X are kept in position, the wires Y are moved proximally and thewires Z are moved distally, then the entire prosthesis 8900 will tiltinto the configuration shown in FIG. 91. Likewise, if the wires X aremoved distally and the wires Y and Z are moved proximally, then theentire prosthesis 8900 will tilt into the configuration shown in FIG.92. Finally, if the wires X are extended distally, the wires Y areextended further distally, and the wires Z are moved proximally, thenthe entire prosthesis 8900 will tilt into the configuration shown inFIG. 93.

Still a further exemplary embodiment of the inventive activelycontrollable stent lattice and the delivery system and method fordelivering the stent lattice are shown in FIGS. 94 to 102. In thisembodiment, the prosthesis 9400 is a stent graft having a proximal,actively controlled stent lattice 110, 3810, 4200, 4600, 6410, 7110 andonly two opposing jack assemblies 700, 2100, 3000, 6430. Instead of twoadditional jack assemblies 700, 2100, 3000, 6430, this embodimentcontains two opposing pivoting disconnector drive blocks 9430. Thesedisconnector drive blocks 9430, as shown for example in the view of FIG.96 rotated circumferentially ninety degrees, have bosses 9432 extendingradially outward and forming the central pivot joint for the twocrossing struts 9410. The two disconnector drive blocks 9430 act aspivots to allow the prosthesis 9400 to tilt in the manner of aswashplate when the two opposing sets of control wires 750, 770 aremoved in opposing distal and proximal directions.

FIG. 94 shows the near set of control wires 750, 770 moved proximallyand the far set moved distally. In FIG. 95, the swashplate of theprosthesis 9400 is untilted, as is the prosthesis 9400 in FIGS. 96 and97, the latter of which is merely rotated ninety degrees as compared tothe former. FIGS. 98 and 99 depict the prosthesis 9400 as part of astent graft having the stent lattice 9810 inside a proximal end of atubular shaped graft 9820.

The prosthesis 9400 in FIGS. 100 to 102 is also a stent graft but, inthis exemplary embodiment, the graft 10010 is bifurcated, for example,to be implanted in an abdominal aorta. FIGS. 101 and 102 show how theproximal end of the prosthesis 9400 can be tilted with the swashplateassembly of the invention, for example, in order to traverse a tortuousvessel in which the prosthesis 9400 is to be implanted, such as aproximal neck of abdominal aortic aneurysm.

The exemplary embodiment of the prosthesis 10300 shown in FIGS. 103 and104 does not include the swashplate assembly. Instead, the deliverysystem includes a distal support structure 10310 that ties all of thesupport bands 10312 to a cylindrical support base 10314 connected at thedistal end of the delivery catheter 10316.

An exemplary embodiment of the entire delivery system 10500 for theprosthesis 10300 is depicted in FIGS. 105 to 107. In FIG. 105, thedelivery system is entirely self-contained and self-powered and includesthe actively controllable stent lattice with an integral control system10510. The prosthesis 10300 is in an expanded state and the graftmaterial is in cross-section to show a rear half. An alternative to theintegral control system 10510 is a wireless control device 10600 thatwirelessly communicates 10610 control commands to the system. Anotheralternative to the integral control system 10510 shown in FIG. 107separates the control device 10700 with a cord 10710 for communicatingcontrol commands to the system. In this exemplary embodiment, thecontrols comprise four rocker switches 10712, 10714, 10716, 10718arranged in a square, each of the switches having a forward position, aneutral central position, and a rearward position.

Yet another exemplary embodiment of a control handle 10800 for operatinga prosthesis having the actively controllable stent lattice according tothe invention is depicted in FIGS. 108 to 118. The views of FIGS. 108and 109 show various sub-assemblies contained within the control handle10800. A user-interface sub-assembly 10810 includes a circuit board10812 having circuitry programmed to carry out operation of the systemsand methods according to the invention. Electronics of theuser-interface sub-assembly 10810 comprise a display 10814 and varioususer input devices 10816, such as buttons, switches, levers, toggles,and the like. A sheath-movement sub-assembly 11000 includes asheath-movement motor 11010, a sheath movement transmission 11020, asheath movement driveshaft 11030, and a translatable delivery sheath11040. A strain relief 11042 is provided to support the delivery sheath11040 at the handle shell 10802. A power sub-assembly 11200 is sized tofit within the handle 10800 in a power cell compartment 11210 containingtherein power contacts 11220 that are electrically connected to at leastthe circuit board 10812 for supplying power to all electronics on thecontrol handle 10800 including all of the motors. A needle-movementsub-assembly 11300 controls deployment of the needles and keeps tensionon the needles continuously even when the delivery sheath 11040 is bentthrough tortuous anatomy and different bends are being imposed on eachof the needles. The needles are three in number in this exemplaryembodiment. Finally, a jack engine 11600 controls all movements withregard to the jack assemblies.

The user-interface sub-assembly 10810 allows the surgeon to obtainreal-time data on all aspects of the delivery system 10800. For example,the display 10814 is programmed to show the user, among otherinformation, deployment status of the stent lattices, the currentdiameter of the stent lattices, any swashplate articulation angle of thestent lattice to better approximate an actual curved landing site, alldata from various sensors in the system, and to give audio feedbackassociated with any of the information. One informational feedback touser can be an indicator on the display 10814 that the delivery sheath11040 is retracted sufficiently far to completely unsheath theprosthesis. Other information can be a force feedback indicator showinghow much force is being imparted on the lattice from the vessel wall,e.g., through a torque meter, a graphical change in resistance to thestepper motor, a mechanical slip clutch, direct load/pressure sensors onlattice. With such information, the prosthesis can have Optimal LatticeExpansion (OLE), achieve its best seal, have a decrease in migration andembolization, and have an amount of outward force limited (i.e., a forceceiling) to stop expansion before tissue damage occurs. A suitably sizedvisual indicator can even show in a 1:1 ratio the actual diameterposition of the stent lattice. Other possible sensors for takingmeasurements inside and/or outside the prosthesis (e.g., above and belowtouchdown points of lattice) can be added into the inventive powereddelivery system or handle. These devices include, for example, a videocamera, a flow wire to detect flow showing blood passing aroundprosthesis/double lumen catheter and showing pressure gradients, aDoppler device, an intrinsic pressure sensor/transducer, an impedance oftouchdown zone, fractional flow reserve, and anintracardiac/intravascular ultrasound. For an example of the lattersensor, an ultrasound device could be incorporated into the nose cone ofthe delivery system and can be extended or retracted to provideassistance in positioning the implant. Additionally and/oralternatively, by measuring pressure above and below the implant,pressure sensors or lumens to pressure sensors located within the handlecan provide a pressure gradient useable to calculate orifice area whencoupled with cardiac output.

Having all of the user interface actuators 10816 within reach of asingle finger of the user provides unique and significant advantages byallowing the surgeon to have one-hand operation of the entire systemthroughout the entire implantation procedure. In all mechanical priorart systems when torque is applied, the second hand is needed. Pushingof single button or toggling a multi-part switch eliminates any need forthe user's second hand. Using different kinds of buttons/switches allowsthe user to be provided with advanced controls, such as the ability tohave coarse and fine adjustments for any sub-procedure. For example,expansion of the lattice can, initially, be coarse by automaticallydirectly expanded out to a given, pre-defined diameter. Then, furtherexpansion can be with fine control, such as a millimeter at a time. Thevarying of diameter can be both in the open and close directions. If theprosthesis needs to be angled, before, during, and/or after varying theexpansion diameter, the user can individually manipulate each jack screwor control wires to gimbal the upstream end of implant so that itcomplies with vessel orientation; both during diameter/articulationchanges, the physician can inject contrast to confirm leak-tightness.Even though the exemplary embodiment of the needle deployment shown ismanual, this deployment can be made automatic so that, once theprosthesis is implanted, and only after the user indicates implantationis final, an automatic deployment of the engaging anchors can be made.With regard to undocking the delivery system, this release can be with asingle touch, for example, of a push button. Also, with an integratedcontrast injection assembly, a single touch can cause injection ofcontrast media at the implantation site.

The sheath-movement sub-assembly 11000 also can be controlled by asingle button or switch on the circuit board 10812. If the userinterface is a two-position toggle, distal depression can correspondwith sheath extension and proximal depression can correspond with sheathretraction. Such a switch is operable to actuate the sheath movementmotor 11010 in the two rotation directions. Rotation of the motor axle11022, therefore, causes the transmission 11024, 11026 tocorrespondingly rotate, thereby forcing the threaded sheath movementdriveshaft 11030 to either extend distally or retract proximally. Theexemplary embodiment of the transmission includes a first gear 11024directly connected to the motor axle 11022. The first gear 11024 ismeshed with the outside teeth of a larger, hollow, driveshaft gear. Theinterior bore of the driveshaft gear 11026 has threads corresponding tothe exterior threads of the sheath movement driveshaft 11030. As such,when the driveshaft gear 11026 rotates, the sheath movement driveshaft11030 translates. The driveshaft gear 11026 is surrounded by a bushing11028 to allow rotation within the housing shell 10802. In order toprevent rotation of the sheath movement driveshaft 11030, as shown inFIG. 111, the sheath movement driveshaft 11030 has a longitudinal keyway11032 that has a cross-sectional shape corresponding to a key that isgrounded to the handle shell 10802. The sheath movement driveshaft 11030also is hollow to accommodate a multi-lumen rod 10804 (shown best inFIG. 112) housing, within each respective lumen, any of the controlwires 750, 770, 2182, 3098 and the guidewire 6610, these lumenscorresponding to those within the wire guide block 116 at the distal endof the delivery sheath 10040.

The size and shape of the power sub-assembly 11200 is limited in shapeonly by the power cell compartment 11210 and the various wires and rodsthat traverse from the needle-movement sub-assembly 11300 and the jackengine 11600 therethrough until they enter the lumens of the multi-lumenrod 10804. Some of these wires and rods are illustrated with dashedlines in FIG. 112. Power distribution to the circuit board 10812 and/orto the motors is carried out through power contacts 11220. Such powerdistribution lines are not illustrated for reasons of clarity. Thismethod or similar such as a rack and pinion or drag wheels can be usedto drive the sheath extension and retraction.

The needle-movement sub-assembly 11300 is described with reference toFIGS. 113 to 115, and best with regard to FIG. 113. Each of the needlerods 11302 that connect to the needles in the prosthesis to theneedle-movement sub-assembly 11300 is associated with a tension spring11310, an overstroke spring 11320, and a control tube 11332. The threecontrol tubes 11332 are longitudinally held with respect to a controlslider 11330 by the overstroke spring 11320. As long as the force on theneedles is not greater than the force of the overstroke spring 11320,movement of the needle rod 11302 will follow the control slider 11330. Aneedle deployment yoke 11340 slides with respect to the shell 10802 ofthe control handle 10800. When the needle deployment yoke 11340 contactsthe control slider 11330 as it moves distally, the needle deploymentyoke 11340 carries the control slider 11330 and the needle rods 11302distally to, thereby, deploy the needles. The transition from FIGS. 113to 114 shows how the tension spring 11310 keeps tension on the needlesby biasing the control slider 11330 proximally. Deployment of theneedles is shown by the transition from FIGS. 114 to 115. As mentionedabove, the needles 3070 each a have bent needle tip 3072. In aconfiguration where the needles 3070 are connected directly all the wayback to the needle-movement sub-assembly 11300, there is a highlikelihood that bending of the delivery catheter 11040 will impartvarious different forces on the needle rods 11302. These forces willtend to pull or push the needle rods 11302 and, thereby possibly extendthe needles 3070 when not desired. Accordingly, each tension spring11310 is longitudinally connected to the needle rod 11302 to compensatefor these movements and keep the bent needle tip 3072 within the needletip groove of the 3013 distal drive block 3010.

Because deployment of the needles is intended (ideally) to be a one-timeoccurrence, a yoke capture 11350 is provided at the end of the yokestroke. Capture of the yoke 11340 can be seen in FIG. 116. Of course,this capture can be released by the user if such release is desired.Finally, if too much force is imparted on the needles when beingdeployed, the force of the overstroke spring 11320 is overcome and thecontrol tube 11332 is allowed to move with respect to the control slider11330. The compression of the overstroke spring 11320 cannot be shown inFIG. 115 because of the limitation of the software that created FIG.115.

The jack engine 11600 is configured to control all rotation of partswithin the various jack assemblies 700, 2100, 3000, 6430. The exemplaryembodiment of the control handle 10800 shown in FIGS. 108 to 118utilizes three jack assemblies similar to jack assemblies 3000 and 6430.In other words, the needles are separate from the proximal drive blocksof both assemblies and only two rotational control wires 750, 770 areneeded. Therefore, for the three jack assemblies, six total controlwires are required—three for the drive wires 750 and three for thedisconnect wires 770. These control wires 750, 770 are guidedrespectively through six throughbores 10806 (surrounding the centralguidewire throughbore 10807 in FIG. 115) and proximally end and arelongitudinally fixed to a distal part 11512 of each of six telescopingwire control columns 11510, shown in FIGS. 115 and 116. All controlwires, even the needle rods 11302, terminate at and are fixedlongitudinally to a distal part 11512 of a respective telescoping wirecontrol column 11510. Each part of these telescoping wire controlcolumns 11510, 11512 are rigid so that rotation of the proximal partthereof causes a corresponding rotation of the distal part 11512 and,thereby, rotation of the corresponding control wire 750 or 770. Thereason why all control wires, even the needle rods 11302, terminate atand are fixed longitudinally to a distal part 11512 of a respectivetelescoping wire control column 11510 is because tortious curving of thewires/rods from their proximal ends to the distal ends longitudinallyfixed at the stent assembly to be implanted will cause the wires to movelongitudinally. If there is no play, the wires/rods will impart alongitudinal force on any parts to which they are grounded, for example,to the threaded connection at the stent assembly at the distal end. Thislongitudinal force is undesirable and is to be avoided to prevent, forexample, the drive screws from breaking loose of their threads. To avoidthis potential problem, the proximal end of each wire/rod islongitudinally fixed to the distal part 11512 of a respectivetelescoping wire control column 11510. The distal part 11512 is keyed tothe wire control column 11510, for example, by having an outer squarerod shape slidably movable inside a corresponding interior squarerod-shaped lumen of the proximal part of the wire control column 11510.In this configuration, therefore, any longitudinal force on any wire/rodwill be taken up by the respective distal part 11512 movinglongitudinally proximal or distal depending on the force being exertedon the respective wire/rod.

Torque limiting is required to prevent breaking the lattice or strippingthe threads of the drive screw. This can be accomplished in software bycurrent limiting or through a clutch mechanism disposed between thedrive motors and the sun gears. An integral contrast injection systemcan be incorporated into the handle of the delivery system throughanother lumen. With a powered handle, therefore, a powered injection aspart of handle is made possible.

Because all of the drive wires 750 need to rotate simultaneously, anddue to the fact that all of the disconnect wires also need to rotatesimultaneously, the jack engine 11600 includes a separate control motor11650, 11670 (see FIG. 115) and separate transmission for each set ofwires 750, 770. The view of FIG. 117 illustrates the transmission forthe drive-screw control motor 11650. At the output shaft 11651 of thedrive-screw control motor 11650 is a first drive gear 11652interconnected with a larger second drive gear 11653. The second drivegear 11653 is part of a coaxial planetary gear assembly and has acentral bore therein for passing therethrough the guidewire 6610. Ahollow rod 11654 is fixedly connected in the central bore and extendsthrough a transmission housing 11610 to a distal side thereof, at whichis a third drive gear 11655, as shown in FIG. 118. The third drive gear11655 is interconnected with three final drive gears 11656, each of thefinal drive gears 11656 being fixedly connected to a respective proximalpart of one of the three telescoping wire control columns 11510associated with each drive wire 750. Accordingly, when the drive-screwcontrol motor 11650 rotates, the three final drive gears 11656 rotatethe control columns 11510 that rotate the drive screws of the jackassemblies 3000, 6430.

The disconnect control motor 11670 operates in a similar manner. Morespecifically and with regard to FIG. 116, the output shaft 11671 of thedisconnect control motor 11670 is a first disconnect gear 11672interconnected with a larger second disconnect gear 11673. The seconddisconnect gear 11673 is part of a coaxial planetary gear assembly andhas a central bore therein for passing therethrough the guidewire 6610.A hollow rod 11674 is fixedly connected in the central bore about thehollow rod 11654 and extends through the transmission housing 11610 tothe distal side thereof, at which is a third disconnect gear 11675 (alsodisposed about the hollow rod 11654), as shown in FIG. 118. The thirddisconnect gear 11675 is interconnected with three final disconnectgears (not illustrated), each of the final disconnect gears beingfixedly connected to a respective proximal part of one of the threetelescoping wire control columns 11510 associated with each disconnectwire 770. Accordingly, when the disconnect control motor 11670 rotates,the three final disconnect gears rotate the control columns 11710 thatrotate the retainer screws of the jack assemblies 3000, 6430. Theactivation of the disconnect drive also unscrews the needle connectionswhen included. One exemplary embodiment for having the needlesdisconnect before the entire implant is set free from the docking jacksprovides a lower number of threads on the needle disconnects.

Not illustrated herein is the presence of a manual release for allactuations of the delivery system. Such manual releases allow for eitheroverride of any or all of the electronic actuations or aborting theimplantation procedure at any time during the surgery. Manual releasesub-assemblies are present for retraction and extension of the deliverysheath, expansion and contraction of all stent lattices, and undockingof all disconnect drive blocks. One exemplary embodiment for each of themanual releases is a lever and ratcheting assembly that permits rotationin only one direction. Manual releases are utilized, for example, whensomething is detected as being wrong, if there is a failure of theelectronics or software, or if the battery dies, and the user desires toremove the delivery system from the patient without implanting the stentlattice or other embodiments of the stent assemblies. With regard to thedelivery sheath, for example, manual release means that it is desired toeither retract or extend the delivery sheath. In the extensiondirection, the delivery sheath is extended as much as possible so thatresheathing can possibly be accomplished, at which time the distal nosecone is retracted into the delivery sheath. In such a situation, themechanism will progressively extend the delivery sheath distally untilthe user determines that the force required to further extend thedelivery sheath is too large or the delivery sheath has extended as faras designed. In each case of the various manual release mechanismsdescribed, the mechanisms will have torque and/or force limiting devicesthat prevent the user from inputting to much force that would break thesystem. In the retraction direction, the delivery sheath is retracted asmuch as possible so that implantation of the implant can still beaccomplished. In such a situation, the mechanism will progressivelyretract the delivery sheath distally until the user determines that theforce required to further extend the delivery sheath is too large or thedelivery sheath has retracted as far as needed for implantation tooccur. With regard to the stent lattice embodiments, manual releasemeans that it is desired to contract the stent lattice as much aspossible. Accordingly, the ratchet will progressively rotate all drivescrews in the direction that causes contraction of the stent lattice. Itis equally possible to have this manual release be bi-directional sothat forcible expansion of the stent lattice can occur. Likewise, aseparate manual release can be uni-directional to only rotate in adirection to expand the stent lattice. With regard to undocking of thedisconnect drive blocks, the manual release would only be used in asituation where implantation was acceptable and desired but, for somereason, one or more of the control tubes preventing disconnect was notallowing the disconnect to occur. In such a situation, a ratchet couldprogressively retract the coils/wires connected to the control tubes. Asthis movement is only longitudinal and is in the nature of a fewmillimeters, the ratchet could be replaced by a lever or pull knob.Finally, with regard to retraction of the nose cone (and its controllumen) manual release means that it is desired to move the nose cone asmuch as possible proximally so that resheathing can possibly beaccomplished. In such a situation, the ratchet will progressivelyretract the nose cone control lumen proximally until the user determinesthat the force required to further retract the nose cone is too large orthe nose cone has retracted as far as desired.

Based upon the above, therefore, the delivery system control handle10800 is entirely self-contained and self-powered and is able toactively control any prosthesis having the stent lattice and jackassemblies of the invention. An alternative embodiment to the combineddrive of multiple control wires with a single motor as described aboveis a configuration providing a single drive motor for each of thecontrol wires. With such a configuration, for example with respect tothe jack screw drives, each motor is monitored for the amount of turnsand synchronized with the other motors so that substantiallysimultaneous rotation of the jack screws occurs. The same monitoring ispossible for the multiple control wires for disconnecting the implant. Abeneficial result of independent driving of control wires is that itbecomes possible to monitor the torque requirements and position of eachdrive wire. If a particular drive wire experiences a variation, thesoftware can have built in allowances (based on testing potentialfaults, such as one drive screw being jammed or rubbing on theimplantation site) to either allow the implantation to continue or tonotify the user that some aspect is in fault. In such a case, the usercan attempt a contraction/re-expansion to clear the fault, or, if neededor desired, a repositioning or recapture of the prosthesis.

An exemplary embodiment of a process for delivering an abdominal aorticstent graft of the invention as shown in FIG. 107 with the stent latticeas a proximal stent is described with regard to the flow chart of FIG.119. The procedure is started in Step 11900 where the lattice has beentranslated through the femoral artery to the implantation site justdownstream of the renal arteries. Actuation of the upper left buttonrearward in Step 11902 causes the delivery sheath 10720 to unsheathefrom the AAA implant 10730 sufficient to expose the actuatable end(e.g., stent lattice) of the implant 10730 (which can be shown, forexample, by the progression from FIG. 217 to FIG. 212—a directionopposite the re-sheathing progression which is shown in the progressionfrom FIGS. 212 to 217). In Step 11904, visualization, such as throughfluoroscopy, provides the user with feedback to show where the distalend 10732 of the prosthesis 10730 is situated. In this position, thestent lattice is in a contracted state (the expanded state is shown inthe view of FIG. 107). Radiopaque markers on the prosthesis 10730 arevisible to show the proximal most points of the prosthesis 10730. InStep 11906, another surgery staff, typically, has marked the location ofthe renal arteries on the screen (on which the surgeon sees the markers)with a pen or marker. In Step 11908, the surgeon translates the latticeof the prosthesis 10730 with the radiopaque markers to a locationtargeted below the renal arteries. The physician begins to expand thelattice in Step 11910 by pressing the upper right button forward (i.e.,forward=open and rearward=close). Depending upon the desire of thesurgeon or as set in the programming of the control device 10700, thelattice can open incrementally (which is desirable due to blood flowissues) or can be expanded fluidly outward. Implantation occurs in Step11912 and has three phases. In the first phase of implantation, thephysician performs a gross orientation of the proximal end of theprosthesis 10730 until touchdown in the abdominal aorta. In the secondphase, the physician fine-tunes the implantation using intermittentexpansion prior to coaptation in all three dimensions and, in the thirdphase, the proximal end of the implant 10730 is either satisfactorilycoapted or, if the physician is not satisfied with the coaptation, thenthe physician reduces the diameter of the stent lattice and starts,again, with phase two. It is noted that the control device 10700 can beprogrammed to, at the first touch of the upper right button, to go to aparticular diameter opening. For example, if the implantation site ispredetermined to be approximately 20 mm, then the control device 10700can be programmed to expand directly to 15 mm and, for each touch of theupper right button thereafter, expansion will only occur by 1 mmincrements no matter how long the upper right button is pushed forward.During Step 11912, the physician is able to view all of the variousfeedback devices on the control handle, such as the real time diameterof the prosthesis, the angulation thereof, a comparison to apredetermined aortic diameter of the touchdown point, an intravascularultrasound assessing proximity to wall, and when wall touch occurs. Withthe digital display 10711 of the invention, the physician can even seean actual representation of the expanding lattice demonstrating all ofthe characteristics above. During the various implantation phases, thephysician can pause at any time to change implant position. Angulationof the stent lattice can be done actively or while paused. As the outergraft material approaches the wall, adjustment of the entire deliverydevice continues until complete coaptation of the prosthesis 10730,where it is insured that the location with respect to the renal arteriesis good, along with proper angulation. As the stent graft touches theaortic wall, the physician can analyze all of the feedback devices andinformation to make implantation changes. At any time if the physicianquestions the implantation, then restart occurs to readjust the stentlattice along with a return to phase two. Further, as coaptation occurs,any other fixation devices can be utilized, for example, passivetines/barbs, a outwardly moving flex-band that presses retention device(e.g., through graft) and into aortic wall, the tissue anchor 7114, andthe graft enclosures 7120. For such devices, there is no secondaryaction required to disengage/retract tines that are engaged. In Step11914, the physician performs an angiogram to determine positioning ofthe implantation (the angiogram can be either separate or integral withthe delivery system 10700), and if the positioning is not as desired(e.g., endoleak), the physician can retract the stent lattice and usethe sheath 10720 to re-collapse the stent lattice using the graftmaterial to ease the delivery sheath 1020 back over the lattice.However, if the physician determines that there is good positioning, thephysician retracts the delivery sheath 10720 by pressing the upper leftbutton rearward until at least contralateral gate is exposed. It isnoted that stabilization of the ipsilateral graft material with thedelivery system 10700 allows for better cannulization of thecontralateral gate for a secondary prosthesis.

In Step 11916, the contralateral limb is deployed as is known in theart. However, if desired, the contralateral limb can also include theactively expanded stent lattice according to the invention. It is alsodesirable to perform a balloon expansion at a graft-to-graft junction ifthe contralateral limb utilizes a self-expanding distal stent. If theactively controllable stent lattice is used, then Steps 11900 to 11914are repeated but for the contralateral limb. In Step 11918, the deliverysheath 10720 is retracted by pressing the upper left button rearwarduntil ipsilateral limb is deployed. The prosthesis 10730 is, now, readyto be finally deployed.

In Step 11920, the physician actuates the lower left button rearward tounscrew the retainer screws and, thereby undock the disconnect driveblocks from the prosthesis 10730. One significant advantage of thedelivery system 10700 is that there is no surge either distal orproximal when undocking occurs and finally releases the prosthesisbecause the entire undocking movement is merely an unscrewing of a rodfrom a threaded hole. Torque imposed on the stent lattice is alsominimized by using counter rotating screws that result in a zero imposedtorque when even in number. It is noted that, for all of the exemplaryembodiment of the stent lattices that utilize the jack screws describedherein, the delivery system does not impart an actuation force either onor to the stent lattices. In other words, the force for changing theconfiguration of the stent lattice is generated entirely within thestent lattice itself. More specifically, the forces that are used toactuate the configuration change of the stent lattice are imposed by thedistal and proximal jack struts. This means that the actuation forcecausing expansion of the stent lattice is delivered and countered withinthe implant independent of the delivery tool.

The upper left button is pressed forward to extend the delivery sheath10720 so that it connects with the distal end of nose cone 10740 whilemaking sure that the open distal end of the delivery sheath 10720 doesnot catch any part of the ipsilateral distal stent or the activelycontrolled proximal stent. It is at this point where a manual overridecould be employed if the surgeon wanted to feel the re-docking of thedelivery sheath 10720 to the nose cone 10740. If desired, using thelower right button pressing rearward, the physician can retract the nosecone 10740 into the distal end of the delivery sheath 10720 with thelower right button. In Step 11922, if the ipsilateral distal stent isself-expanding, the physician performs a final balloon expansion.However, if the ipsilateral distal stent utilizes the activelycontrollable stent lattice of the invention, Steps 11900 to 11914 arerepeated but for the ipsilateral limb. A completion angiogram isperformed in Step 11924 to make sure the prosthesis did not shift andthat all leak possibilities have been ruled out. In an exemplaryembodiment where the control system 10700 includes an integral dyesystem, the physician would extend the system proximal to the proximalactive lattice to perform this angiogram. Finally, in Step 11926, thelower right button is pressed rearward to retract the delivery system asmuch as possible into the handle and, in Step 11928, the delivery system10700 is removed from the patient.

FIG. 120 shows an exemplary embodiment of aself-expanding/forcibly-expanding lattice of an implantable stentassembly 12000 having nine lattice segments 12010 in a self-expandednative position as will be described below. In one exemplary embodiment,each of the nine lattice segments is formed with one-half of either athreaded or smooth bore 12012 for respective coordination with either athreaded or smooth portion of a jack screw 12020. In another exemplaryembodiment, the nine lattice segments are formed from one integral pieceof a shape memory metal (e.g., Nitinol or other super-elastic material)and with a jack screw 12020 disposed between adjacent pairs of repeatingportions of the lattice and through the wall of the stent lattice. Inthe views shown in FIGS. 120 and 121, each jack screw 12020 is placed ina non-engaged state to allow crimp of the stent lattice for loading intoa stent delivery system. In this regard, FIG. 121 illustrates the stentassembly 12000 in a contracted/crimped state for loading into the stentdelivery system, an example of which is illustrated in the progressionof FIGS. 217 to 212. In this non-engaged state, as the stent assembly12000 is crimped for delivery, the proximal jack strut 12014 surroundingthe non-threaded portion of each jack screw 12020 can slide thereaboutwith play between the two positions shown in FIGS. 120 and 121 withouthindrance or bottoming out the distal drive screw coupler part 12052while the lattice expands longitudinally when contracted by the deliverysheath of the delivery system. When the stent assembly 12000 is allowedto self-expand back to the position shown in FIG. 120, the jack screw12020 moves into the bore of the distal jack strut 12014 until thedistal drive screw coupler part 12052 hits the proximal end of theproximal jack strut 12014. Accordingly, with rotation of the jack screw12020 in the stent-expansion direction, after the distal drive screwcoupler part 12052 hits the proximal end of the proximal jack strut12012, further lattice-expanding movement of the drive screw 12020starts moving the proximal jack strut 12014 towards the distal jackstrut 12013 to expand the stent assembly 12000.

Longitudinally, the stent assembly 12000 is provided with pairs of jackstruts 12013, 12014 connected by a respective jack screw 12020 andintermediate non-moving struts 12030. In the exemplary embodiment of thestent assembly 12000 shown, there are nine pairs of jack struts 12013,12014 and nine non-moving struts 12030. This number is merely exemplaryand there can be, for example, only six of each or any other numberdesired. Connecting the pairs of jack struts 12013, 12014 and thenon-moving struts 12030 are laterally extending arms 12040. As the stentassembly 12000 is either contracted or expanded, the arms 12040 eachflex at their two endpoints, one at a respective non-moving strut 12030and the other at a respective one of a pair of jack struts 12013, 12014.As can be seen from the configuration shown in FIG. 121, when the stentassembly 12000 is contracted (e.g., for installation into the deliverysheath), the arms 12040 move towards a longitudinal orientation.Conversely, when the stent assembly 12000 is expanded (e.g., forimplantation), the arms 12040 move towards a radial orientation.

FIG. 122 shows the lattice after being allowed to return to its nativeposition, for example, at a deployment site. Each jack screw 12020 is inan engaged state for controlled further outward expansion of thelattice. As the lattice is sized for implantation, the delivery systemforcibly expands the lattice, as shown in the progression of FIGS. 123,124, and 125. In the view of FIG. 125, the lattice is about to enter amaximum expansion state, which occurs when the proximal surface of thedistal jack strut 12013 contacts the distal surface of the proximal jackstrut 12014. It is noted that this exemplary embodiment does not showfeatures of a valve sub-assembly. Valve sub-assemblies, such as shown inFIGS. 135 to 136 are envisioned to be used with this stent assembly12000 but are not shown for reasons of clarity.

This exemplary embodiment and other exemplary embodiments of theself-expanding, forcibly expanding stent lattices described hereincircumscribe cells 12310 that are comprised of either the distal jack orproximal jack part, a portion of the non-moving strut, and two arms,which together define a parallelogram (one of which is outlined in FIG.123 with dashed lines). This shape is beneficial because it keeps themoving struts (e.g., 12013, 12014) parallel as they expand and contract,thus keeping the distal and proximal jack parts aligned with the jackscrew 12020 to insure stability of the lattice. More specifically, anypitch, roll, or yaw movements of either of the jack parts (e.g., 12013,12014) or the non-moving struts (e.g., 12030) is substantially preventedby this configuration. The configuration of adjacent cells providessignificant benefits and differences from the above-mentioned scissorlattice or braided lattice structures, respectively, where mechanicalpivots are present at crossings of two members or where two wires of astent lattice or braid cross and change angles relative to one anotherto form a scissor when changing geometrically. In the embodiments ofstent lattices described herein, no wires or members cross. Thus,without the presence of any scissoring members, the ability to sew tothe stent lattice becomes possible. Further, the stent lattices are ableto use all of the wall thickness for strength (there is no point wheretwo thinner members are crossing one another). Additionally, the entirestent lattices have no points of instability and are more stable becausethe lattice is one continuous piece of material (with the exception ofthe configurations similar to FIG. 126, where the continuity is formedby fixation, such as welding or soldering).

FIG. 126 is an alternative exemplary embodiment of a portion of aself-expanding/forcibly-expanding lattice of an implantable stentassembly 12600. In the portion of the configuration shown, a separatejack screw assembly 12610 connects the two adjacent lattice segments(here the non-moving strut 12616 is shown in a vertical cross-sectionpassing through the mid-line thereof). Separate jack tube halves 12612,12613 are connected respectively to upper and lower jack-contact struts12614 of the two adjacent lattice segments. To fix these tubes to thenitinol lattice, the tubes can, for example, be made of Niobium. In theexemplary embodiment shown, the external threads of the jack screw 12620are engaged with the interior threads of the distal jack tube half12612. A lattice-disconnect tube 12630 of the stent delivery system isengaged to cover a pair of drive screw coupler parts therein. FIG. 127shows the lattice-disconnect tube 12630 disengaged from an exemplaryembodiment of a pair of drive screw coupler parts 12752, 12754. Thisconnected state of the pair of drive screw coupler parts 12752, 12754 isidealized because, due to the natural lateral/radial forces existing inthe disconnect joint, once the lattice-disconnect tube 12630 retractsproximally past the coupling of the drive screw coupler parts 12752,12754, the two drive screw coupler parts 12752, 12754 will naturallyseparate, as shown in the view of FIG. 128. In the disconnected view ofFIG. 128, the proximal member of the pair of drive screw coupler parts12752, 12754, which is part of the delivery system, is partiallyretracted into the central bore of the lattice-disconnect tube 12630.

FIG. 129 illustrates another exemplary embodiment of aself-expanding/forcibly-expanding lattice of an implantable stentassembly. This assembly also has nine separate lattice segments, butmore or less in number is equally possible, for example, six segments.In this embodiment, a proximal disconnect block 12930 and disconnectsubassemblies 12931, 12932 of a stent delivery system is an alternativeto the lattice-disconnect tubes 12630 of the embodiment of FIGS. 126 to128. Here, a proximal disconnect block 12930 is in an engaged statecovering the pair of drive screw coupler parts 13052, 13054 therein.After the disconnect block 12930 is retracted in a proximal direction,all of the lattice-disconnect arms 12932 are removed from covering thepair of drive screw coupler parts 13052, 13054, thereby allowingdisconnect of the lattice 12900 from the delivery system, as shown inFIG. 130. The proximal disconnect block 12930 allows all of the pairs ofdrive screw coupler parts 13052, 13054 to be coupled together forsubstantially simultaneous release.

FIGS. 131 and 132 show an alternative to the exemplary embodiment of theself-expanding/forcibly-expanding lattice of FIGS. 126 to 130. Here, theintermediate jack tubes halves 13112, 13113 for receiving one jack screw13120 therein are connected to the adjacent lattice segments with theadjacent lattice segments 13114 not directly on opposing sides of thejack tubes 13112, 13113. The angle that the two adjacent latticesegments make is less than 180 degrees and greater than 90 degrees. Inparticular, the angle is between 130 degrees and 150 degrees and, morespecifically, is about 140 degrees, as shown in FIG. 132.

FIG. 133 is another exemplary embodiment of aself-expanding/forcibly-expanding lattice of an implantable stentassembly 13300. In this embodiment, there are nine lattice segments butmore or less is equally possible, for example, six segments. Here, thedistal and proximal jack struts 13313, 13314 of the lattice are locallythicker to accommodate and connect to non-illustrated jack screwassemblies. One possible method of fabricating the stent lattice withlocally thicker sections is to start with a tube of material that is atleast as thick as the thickest region and to wire-EDM one of or both ofthe inside and outside surfaces to cut out the narrower sections andeither form or leave the locally thicker sections. This applies to allof the exemplary embodiments of the stent lattice herein where locallythicker sections appear.

FIG. 134 is another exemplary embodiment of aself-expanding/forcibly-expanding lattice of an implantable stentassembly 13400. In this embodiment, there are nine lattice segments butmore or less is equally possible, for example, six segments. Instead ofhaving the non-illustrated jack screws pass entirely through thematerial of the lattice as shown in previous embodiments, here, the jackstruts of the lattice are elongated and the elongated portions arebent-over to form tabs 13413, 13414 for connecting to non-illustratedjack screw assemblies. The tabs 13413, 13414 are shown here as bentinwards, but they can also be bent to face outwards. To operate thejacks, various ones of each of the set of longitudinal tabs are threadedor smooth.

FIGS. 135 to 137 show another exemplary embodiment of theself-expanding/forcibly-expanding lattice of an implantable valveassembly 13500. The jack assemblies are similar to the embodiment ofFIGS. 120 to 125. Here, however, there are six lattice segments. Theintermediate non-moving struts 13530 between the jacks 13520 formcommisure connections and include through-bores 13532 for connecting thevalve end points of the intermediate valve 13540 to the lattice. In thisembodiment, the upper plane of the valve 13540 is in line with the upperend of the non-moving struts 13530, which are at the same plane as theupper end of the jacks 13520. The valve 13540 here is shown with threeleaflets 13542 and, therefore, three commisure connections exist atthree of the non-moving struts 13530. The valve assembly is shown inFIGS. 135 and 136 in an expanded position that can be commensurate withan implantation position of the valve assembly. FIG. 137, in comparison,shows the lattice of the valve assembly 13500 in a natural or pre-set,non-forcibly-expanded state. There exist some reasons for having thelattice of the valve assembly 13500 be set to a larger natural diameterthan the compressed, pre-implantation size as shown in FIG. 121 or 139.For example, in such a configuration, it is desirable to have the angleof the arms of the lattice, when starting to force drive, not be shallowbecause it is desired to have all of the force of the screw to drive thediameter change of the stent assembly. Also, when driving the stentassembly from a natural position to a final, forcibly open position,strain is induced in the material. It is understood that, the higher theinduced strain, the greater the installed strain, increasing thepossibility of failure. Therefore, the closer the final position is tothe natural position, the lower is the installed strain. Further, thenatural position cannot be made so large because there will be too muchstrain to collapse the lattice for delivery. In this regard, theheat-set diameter of the stent lattices of the disclosed exemplaryembodiments is optimized so that the strain imparted when moving thestent lattice from its heat-set diameter to the crimped diameter ismaximized within the allowable super-elastic range of the material,therefore, minimizing the installed strain when the stent lattice ismoved from its heat-set diameter to the forcibly expanded implantationdiameter.

FIGS. 138 to 142 show another exemplary embodiment of theself-expanding/forcibly-expanding lattice of a stent assembly 13800. Asin the above embodiments, this exemplary embodiment does not showfeatures of a valve sub-assembly for reasons of clarity even thoughvalve sub-assemblies, such as shown in FIGS. 135 to 136, are envisionedto be used with this stent assembly 13800. Here, the lattice of thestent assembly 13800 has six lattice segments. Instead of having thejack screws contact longitudinal bores in the wall of the lattice, pairsof jack tubes 13812, 13813 are connected (e.g., laser welded) torespective longitudinal pairs of jack connection struts 13822, 13823.This embodiment shows the jack tubes 13812, 13813 connected on theinterior of the lattice but they can also be connected on the exterior,or the pairs can even be staggered on the interior and exterior in anyway and in any number. The jack tubes 13812, 13813 are formed withinterior threads or interior smooth bores.

After being forcibly contracted, the lattice of FIG. 138 can be furthercompressed within the delivery sheath of the delivery system, anorientation that is shown in FIG. 139. After delivery to theimplantation site, the lattice is expanded for implementation, firstnaturally and then forcibly. FIGS. 140 to 142 show various expansionstages of the lattice in various perspective views with FIG. 142 showingthe lattice expanded near a maximum expansion extent.

An alternative to forming interior-threaded, longitudinal through-boresin the lattice is shown in the exemplary embodiment of FIGS. 143 to 154.Here, the self-expanding/forcibly-expanding lattice of an implantablestent assembly 14300 has nine lattice segments. FIG. 143 shows thelattice in a native, self-expanded position. Both of the distal andproximal jack struts 14313, 14314 in each of the nine segments havesmooth bores. The distal jack strut 14313 in each lattice segment has aproximal end formed as a first connection part 14315 shaped to receivethereat a second connection part 14330. It is this second connectionpart 14330 that contains the interior threads for threadingly matingwith the exterior threads of the jack screw 14320. In an exemplaryembodiment, the second connection part described herein can be madecurved from tube-stock to fit within wall of the stent assembly whencollapsed. Additionally, the drive screws and/or the second connectionpart can be made of materials that do not have galvanic corrosion, suchas Titanium. By locking the two connection parts 14315, 14330 at leastin the longitudinal direction of the lattice (for example by theopposing T-shaped tongue and grooves shown in FIG. 143), when the jackscrew 14320 (longitudinally secured at the proximal side of the proximaljack strut 14314 by the distal drive screw coupler part 12052) isthreaded into the second connection part 14330, a two-sided connectionis formed that allows each jack assembly to function by moving therespective pair of longitudinally aligned jack struts 14313, 14314towards or away from one another. In the exemplary embodiment, the firstconnection part 14315 has a T-shape and the second connection part 14330is a nut having a bore with an interior shape corresponding to theexterior of the T-shape of the first connection part 14315. Thisconfiguration, therefore, forms a form-locking connection. Aform-locking or form-fitting connection is one that connects twoelements together due to the shape of the elements themselves, asopposed to a force-locking connection, which locks the elements togetherby force external to the elements. By creating a threaded interior borein the second connection part 14330 that is co-axial with the smoothbores of the distal and proximal jack struts 14313, 14314, once the jackscrew 14320 is threaded completely through the second connection part14330 and enters the bore of the distal jack strut 14313, the jack screw14320 prevents the second connection part 14330 from being removed. FIG.153 illustrates the interior threads of the nut and shows how the jackscrew 14320 prevents removal of the nut 14330 after the jack screw 14320passes completely therethrough.

In these figures, an exemplary embodiment of commisure connector pads14350 for each of three commisure points of the valve leaflets areprovided. An exemplary form for the commisure connector pads 14350 is arectangle with four through-bores for suturing the commisure pointthereto. Outer lattice fixation paddles 14360 are provided at the endsof the non-moving struts 14316 to improve fixation of the stent assembly14300 in the implantation site.

As can be seen by the progression from FIGS. 145 to 146, thelattice-disconnect tubes 14340 move proximally in order to disconnectthe pair of drive screw coupler parts 14652, 14654. FIG. 146 shows thelattice of FIG. 143 with the connector control tubes 14340 of thedelivery system in a non-engaged state after disconnection of the stentassembly 14300 by the delivery system has occurred. FIG. 149 shows thelattice expanded by the jack screw assemblies almost up to the fullestexpanded extent possible, where the two jack struts 14313, 14314 of thelattice almost touch. Various other views of the stent assembly 14300are shown in FIG. 144 (top view), FIGS. 147, 148 and 152 (enlarged viewsof the connection parts expanded and contracted), and FIGS. 150 and 151(contracted stent assembly). FIG. 144 reveals that, in an exemplaryembodiment of the jack struts 14652, 14654, the radial thickness 14410is greater than a thickness 14420 of the remainder of the stent lattice,in this case, it is thicker from the interior of the lattice. Ifdesired, it can be thicker from the exterior of the lattice.

FIG. 154 shows one exemplary embodiment of the lattice 14300′ of FIG.143 in an intermediate manufacturing step before the cylindrical stentassembly 14300 is created. For example, the lattice of the stentassembly can be laser cut from a sheet of Nitinol, wrapped around amandrel, and welded at the two ends to form the shape of the lattice14300 shown in FIG. 143.

FIGS. 155 to 166 illustrate another exemplary embodiment of aself-expanding/forcibly-expanding lattice of an implantable stentassembly 15500 having six lattice segments. As best seen in FIGS. 156and 159, the jack struts 15513, 15514 have keyhole slots to accommodatethe jack screws therein. This exemplary embodiment, therefore, cancreate the keyhole slots using a wire-EDM (electric discharge machining)process. This exemplary embodiment shows the keyhole slots open to theinside but, as described below, the keyhole slots can also be open tothe outside.

The configuration of the stent assembly 15500 has similar features ofthe stent assembly 14300, all of which are not repeated for the sake ofbrevity. One feature of the stent assembly, for example, similarly hascommisure connector paddles 15550 for each of three commisure points ofthe valve leaflets. This exemplary form for the commisure connectorpaddles 15550 is a waffle pattern with five through-bores and dimpledsides for suturing the commisure point thereto. The stent assembly 15500also has some differences from the stent assembly 14300. A firstdifference is that outer lattice fixation pads 15560 on the non-movingstruts 15516 are bent outwards to shape the lattice into a longitudinalhourglass. As particularly shown in the views of FIGS. 159 and 160, theouter lattice fixation pads 15560 each provide a beneficial location atthe a distal end thereof for placing a radiopaque marker 15562.

FIG. 155 shows the stent assembly 15500 partially expanded state witheach of the jack screws 15520 in a thread-engaged state for furtheroutward expansion. As can be seen in FIG. 155, turning the jack screws15520 so that they enter the second connection part 15530 further pullsthe distal jack strut 15513 towards the proximal jack strut 15514(because the distal drive screw coupler part 14652 is prevented fromfurther distal longitudinal movement after hitting the proximal side ofthe proximal jack strut 15514). It is noted, however, that this pullingdoes not occur until the jack screws 15520 enter the distal jack strut15513 to eliminate any slack that exists between the distal drive screwcoupler part 14652 and the proximal most surface of the proximal jackstrut 15514. When the distal drive screw coupler part 14652 finallytouches the proximal end of the proximal jack strut 15514, furtherrotation of the jack screws 15520 cause the distal and proximal jackstruts 15513, 15514 to move towards one another because the threads ofthe jack screws 15520 are connected with the internal threads of thesecond connection part 11530. As is apparent, because the stent assembly15500 is forcibly expanded in this state, reversing the jack screws15520 allows the stent assembly 15500 to retract radially inwardstowards it natural state, which is shown, for example, in FIG. 161.FIGS. 157, 158, 160, 165, and 166 also show the stent assembly 15500 invarious forcibly expanded configuration states.

However, when it is desired to forcibly contract the stent assembly15500, further reversal of the jack screws 15520 will merely turn thescrews out of the respective second connection parts 11530. To preventthis removal from occurring (because removal of the jack screws 15522from the second connection part 15530 would allow the latter to fall offthe stent lattice), each of the jack screws 15520 is provided with aback drive sleeve 15570 that is disposed fixedly on the outside of eachof the jack screws 15520 at a location between the second connectionpart 15530 and the distal surface of the proximal jack strut 15514. Tofix the back drive sleeve 15570 in place, it can be, for example,machined directly with the screw or laser welded on as secondaryprocess. Use of the back drive sleeve 15570 to cause forciblecontraction of the stent assembly 15500 can be seen in the transitionfrom FIG. 161 to FIG. 162 to FIG. 163. In FIG. 161, the jack screws15520 are in a position where the lattice is in the natural,self-expanded state but in a position where the distal drive screwcoupler part 14652 touches the proximal-most surface of the proximaljack strut 15514. In this position an unscrewing movement of the jackscrews 15520 causes no movement of the lattice until the back drivesleeve 15570 touches the distal-most surface of the proximal jack strut15514, which is the position shown in FIG. 162. Any further reversal ofthe jack screws 15520 causes the distal portion of the jack screws 15520to begin moving away from the distal jack strut 15513 but the back drivesleeve 15570 prevents any longitudinal movement of the jack screws 15520with respect to the proximal jack strut 15514. As a result, the distaland proximal jack struts 15513, 15514 are forced apart to cause inwardcontraction of the stent assembly 15550. Once the stent assembly 15550is contracted sufficiently to be loaded into the delivery sheath(indicated diagrammatically in with dashed lines 16400 in FIG. 164), anyfurther inward contraction can be effected by forcibly loading thelattice into the delivery sheath of the delivery system forimplantation. Loading the lattice into the delivery sheath can be seenin the progression from FIG. 217 to FIG. 212.

FIGS. 167 and 168 show another exemplary embodiment of aself-expanding/forcibly-expanding lattice of the implantable stentassembly of FIGS. 155 to 166. Here, the lattice also has six latticesegments but the longitudinal location of each intermediate jack screwnut to a respective one of the second connection parts 16730 isstaggered longitudinally about the circumference of the lattice. Thisexemplary embodiment shows the staggering of the second connection parts16730 in only two longitudinal positions (i.e., at two cross-sectionalplanes). However, three or more different longitudinal positions arealso envisioned. FIG. 168 illustrates how the lattice is able to becollapsed even further than a configuration where all of the secondconnection parts 16730 are in the same radial plane (i.e.,cross-sectional plane). As can be seen, the second connection parts16730 do not hit one another during contraction. Not only does thestaggered orientation reduce the impact of the second connection parts16730 on the cross-section for available space, this configuration alsoreduces impact on the circumferential length where, with regard to FIG.168, it can be seen that the second connection parts 16730 touch metalin the lattice directly adjacent the second connection parts 16730, e.g.at the lattice arms.

FIGS. 169 to 173 show a distal end of an exemplary embodiment of adelivery system containing the stent assembly 15500 of FIGS. 155 to 166,which is only shown as a stent lattice. Of course any of the stentassemblies described herein can be substituted for this stent lattice,including valve assemblies. Use of the stent assembly 15500 in thisexemplary embodiment is merely for illustration purposes. The view ofFIG. 169 shows the state of the lattice after the delivery sheath 11040of the delivery system has been withdrawn to an implantation positionand after the lattice has been forcibly expanded, for example, to animplantation size of the lattice.

In addition to the stent assembly 15500, distal portions of the stentdelivery system are shown. First, lattice-disconnect tubes 16940 areconnected to disconnect wires 770 which, in this embodiment, take theform of hollow flexible coils. Accordingly, proximal movement of thedisconnect coils 770 causes movement of the lattice-disconnect tubes16940 as shown in the progression of FIGS. 170 to 171 to 172. Thedisconnect coils 770 each have disposed therein a respective one of thedrive wires 750 that cause rotation of each of the proximal drive screwcoupler parts 14654 for expansion and contraction of the stent assembly15500. Also shown is a distal nose cone 16920 defining therein at leasta longitudinal guidewire lumen (not illustrated). Connecting the nosecone 16920 to the remainder of the delivery system is a hollow guidewire tube 16922 having a guidewire lumen coaxial with the guidewirelumen of the nose cone 16920 for a guidewire that is used to guide thedelivery system to the implantation site (see, e.g., FIGS. 66 to 69).Containing the stent assembly 15500 during delivery is the deliverysheath 11040, which is shown in the retracted state in FIG. 169 forimplantation of the stent assembly 15500.

FIG. 170 shows the interior of the delivery system of FIG. 169 proximalof the stent assembly to be implanted by the delivery system by theremoval of the delivery sheath in this figure to a point proximal of theconnector control sub-assembly 17000 of the delivery system. Theconnector control sub-assembly 17000 is shown fragmented in FIG. 170 forclarity. The progression of the connector control sub-assembly 17000 inFIGS. 170 to 171 to 172 illustrates how the stent assembly 15500 isactively disconnected (arrow A) from the delivery system.

In the connector control sub-assembly 17000, each of the disconnectcoils 770 is grounded to a disconnect puck 17020. Accordingly, controlof the stent disconnect by the delivery system is effected by retractingthe disconnect puck 17020 a proximal distance sufficient to remove thelattice-disconnect tubes 16940 from covering the drive screw couplerparts 14652, 14654, which movement is illustrated in the progression ofFIGS. 171 and 172. In FIG. 170, the connector control sub-assembly 17000is in a lattice-connected state with the lattice-disconnect tubes 16940over the drive screw coupler parts 14652, 14654. Proximal retraction ofthe disconnect coils 770 causes all of the lattice-disconnect tubes16940 to move proximally into a lattice-disconnected state, shown inFIG. 171. In this figure, each of the lattice-disconnect tubes 16940 isrespectively retracted proximally from each of the drive screw couplerparts 14652, 14654 an instant before all of the drive screw couplerparts 14652, 14654 disconnect from one another. It is noted that theconnection of the drive screw coupler parts 14652, 14654 illustrated inFIG. 171 with the lattice-disconnect tubes 16940 disengaged from thepair of drive screw coupler parts 14652, 14654 is idealized because, dueto the natural lateral/radial forces existing in the disconnect joint,once a lattice-disconnect tube 16940 retracts proximally past thecoupling of these drive screw coupler parts 14652, 14654, the two drivescrew coupler parts 14652, 14654 will naturally separate, as shown inthe view of FIG. 172. In actuality, manufacturing tolerances andvariable resistance will have the jack-screw-connector pairs disconnectat different times, even if they are microsecond from one another. FIG.172 shows the connector control sub-assembly 17000 in alattice-disconnected state where each of the drive screw coupler parts14652, 14654 are disconnected from one another.

FIGS. 170 and 173 are enlarged views of various details illustrating howthe disconnect coils 770 are retracted simultaneously for substantiallysimultaneous disconnection of the drive screw coupler parts 14652,14654. More specifically, each of the lattice-disconnect tubes 16940 islongitudinally fixed to a respective disconnect coil 770 at the distalend of the disconnect coil 770. Two sleeves 17022, 17024 are fixed tothe proximal end of each disconnect coil 770. The disconnect puck 17020has a number of passages 17021 equal to the number of disconnect coils770 (which also is equal to the number of jack screw assemblies). As canbe seen in FIGS. 170 and 173, attachment of the proximal end of thedisconnect coils 770 to the disconnect puck 17020 occurs by firstplacing the distal sleeve 17022 in a respective distal counterbore ofone passage 17021 of the disconnect puck 17020. The passages eachcomprise the distal counterbore, an intermediate groove, and a proximalcounterbore. At this point, the proximal end of the disconnect coil 770and the proximal sleeve 17024 stick out from the side of the disconnectpuck 17020. Then, the coil 770 is slightly stretched so that theproximal sleeve 17024 moves over the proximal corner of the disconnectpuck 17020 and is allowed to move down and rest inside the proximalcounterbore, shown in FIGS. 171 to 173. Even though longitudinally fixedafter such a connection, the entire sub-assembly at the proximal end ofthe coils 770, including the distal and proximal sleeves 17022, 17024,is freely rotatable within its respective passage 17021. When torque istransmitted through the drive screw coupler parts 14652, 14654, a strongoutward radial force separating the drive screw coupler parts 14652,14654 exists. This separating force is counteracted by the sleeve 16940.To prevent drag upon the rotating drive mechanism that houses the drivescrew coupler parts 14652, 14654 therein, the sleeve 16940 is allowed tospin freely within the puck passages 17021.

The disconnect puck 17020 is longitudinally slidable about the centralhollow shaft of the guidewire tube 16922. Proximal of the disconnectpuck 17020 but longitudinally fixed to the central guidewire tube 16922is a control spool 17030. The control spool 17030 has puck controlscrews 17032 rotationally freely connected thereto but threaded inrespective internally threaded bores of the disconnect puck 17020. Thesepuck control screws 17032 are connected proximally to the disconnectdrive subsystem in the delivery system handle through the deliverysheath 11040. In this way, rotation of the puck control screws 17032allows distal and proximal movement of the disconnect puck 17020, whichcorresponds to distal and proximal movement of the lattice-disconnecttubes 16940. Not illustrated in FIGS. 170 to 173 but shown in FIG. 178is an O-ring 17800 that is pierced by all of the wires passing throughthe control spool 17030 and is made of a polymer to provide afluid-tight seal preventing flow of blood into the delivery sheathand/or delivery system handle.

It is noted that the position of the delivery sheath 11040 in the viewof FIG. 169 covers the disconnect puck 17020 and prevents the disconnectcoils 770 from coming out of the disconnect puck 17020. Accordingly, inuse, the delivery sheath 11040 is retracted proximally no further thanis shown in FIG. 169.

As in previous embodiments described herein, each jack assembly of thestent assembly utilizes one set of control wires, one driving wire 750(here, rotational) and one disconnect wire 770 (here, longitudinallyactuated). Also described in this exemplary embodiment are puck controlscrews 17032. Each of the driving wires 750 and the puck control screws17032 extends from the connector control sub-assembly 17000 all the waydistal to the control handle of the delivery system. Because thedelivery sheath 11040 is flexible and is intended to move throughtortuous anatomy, it is understood that all of these wires/rods willexperience longitudinal forces and will move longitudinally as thedelivery sheath 11040 bends. As any longitudinal force exerting on thesewires/rods is undesirable, especially with the disconnect wire 770—whichcauses removal of the lattice-disconnect tubes 16940 and completedisconnection of the stent assembly when the lattice-disconnect tubes16940 are moved proximally, it is important to minimize any affect thatsuch forces would have on any of the wires/rods.

To eliminate action of such forces on the distal end of the device, thewires/rods are all grounded to the control spool 17030. As shown inFIGS. 170 to 172, and in particular FIG. 173, each of the puck controlscrews 17032 have puck grounding cuffs 17033 on either side of thecontrol spool 17030 that allow rotation movement but preventlongitudinal movement. Similarly, the drive wires 750 each have drivegrounding cuffs 751 on either side of the control spool 17030 that allowrotation movement but prevent longitudinal movement.

All of these control wires/rods terminate at and are fixedlongitudinally to a distal part 11512 of a respective telescoping wirecontrol column 11510. Each part of these telescoping wire controlcolumns 11510, 11512 are rigid so that rotation of the proximal partthereof 11510 causes a corresponding rotation of the distal part 11512and, thereby, rotation of the corresponding control wire 750, 17032. Thedistal part 11512 is keyed to the wire control column 11510, forexample, by having an outer square rod shape slidably movable inside acorresponding interior square rod-shaped lumen of the proximal part ofthe wire control column 11510. In this configuration, therefore, anylongitudinal force on any wire/rod will be taken up by the respectivedistal part 11512 moving longitudinally proximal or distal depending onthe force being exerted on the respective wire/rod and virtually nolongitudinal force will be imparted distal of the control spool 17030.

FIGS. 174 to 177 are photographs of an exemplary embodiment of adelivery system and stent assembly lattice similar to the configurationshown in FIGS. 167 to 168. These views show the lattice in variousrotational views and in a forcibly expanded state with the back drivesleeve 15570 clearly appearing on the jack screw 15520. FIGS. 178 to 180show additional views of the connector control sub-assembly 17000 of thedelivery system. In addition to the outer delivery sheath 11040surrounding all of the control wires/rods, also provided is a flexiblemulti-lumen extrusion 17810, shown in FIG. 178, which provides aseparate, independent lumen for each of the driving wires 750 and thepuck control screws 17032.

FIGS. 181 to 194 are photographs of various different exemplaryembodiments of self-expanding/forcibly-expanding implantable heart valveassemblies. FIGS. 181 to 186 show a heart valve assembly having ninelattice segments in an expanded state and with valve leaflets in an openstate. In this embodiment, the outer lattice fixation pads 15560 on thenon-moving struts 15516 are bent outwards to shape the lattice into alongitudinal hourglass. The valve leaflets 18110 are connected bycommisure plates 18120 to the non-moving struts 15516. The proximal endsof the drive screw coupler parts 14652 are shown in FIG. 186.

FIGS. 187 to 194 show a heart valve assembly having six lattice segmentsin an expanded state and with valve leaflets in an open state. The viewof FIG. 188 shows only the valve leaflet sub-assembly 18800 removed fromthe lattice. Easily viewed in FIG. 188 is an exemplary embodiment of acommisure connector 18810 that is shown installed within the stentlattice of FIGS. 189, 190, and 208. This commisure connector 18810allows for easier connection of a single surface valve sub-assembly18800. When so used, the valve sub-assembly 18800 traversesapproximately the dashed line shown in FIG. 208 as seen in FIGS. 189 and190. The commisures of the various embodiments described herein areattached to the non-moving or rigid portions of the lattice, forexample, at the non-moving strut or at the proximal jack strut adjacentthe downstream end of the valve sub-assembly.

In the exemplary embodiment of FIGS. 190 to 192, the upper plane of thevalve leaflet sub-assembly 19000 is in line with the upper end of thecommisure connector paddles 15550 on the non-moving struts 15516, whichare significantly longer and are not at the same plane as the upper endof the proximal jack struts 15514. Here, the plane of the upper end ofthe proximal jack struts 15514 is in line with the downstream end of thegraft material 19010.

In an alternative, non-illustrated configuration of the self-expandingand forcibly expanding stent lattice, the commisures are fixed to thenon-moving strut 19016 at a point 19020 between the outer row of arms19040 extending away from either side of the non-moving strut 19016 andthe first row of arms 19042 closer to the center of the stent lattice.In such a configuration, the loads applied by the valve leafletsub-assembly 19000 are spread to a greater number of support areas,thereby reducing the stress and strain upon the arms 19040, 19042. Inparticular, in such a configuration, the forces are spread to four arms19040, 19042, whereas in previously described configurations, the forcesare born principally by the two outer-most arms 19040. One reason forthis is because each arm has a mean installed strain that is generatedby the forcibly expanding portion of the implantation. The same areaswill experience additional strain associated with supporting the valveleaflets. In order for the stent lattice to survive long-term fatigueassociated with high cycles of use, the alternating strain should bebelow a threshold and this process of spreading the forces to more armsallows the threshold to be maintained.

FIG. 191 shows an exemplary embodiment of a heart valve assemblyconnected to an exemplary embodiment of a delivery system and forciblyexpanded. Here, the shape of the graft material is shown ascorresponding to the shape of the upstream arms as in a saw toothpattern.

The views of FIGS. 192 to 194 show an exemplary embodiment of how thegraft and how the leaflet sub-assembly are connected to the lattice.FIGS. 193 to 194 show how the braid angle of the braided graft material19310 closely matches the angle of the arm portions of theself-expanding/forcibly-expanding implantable heart valve. In this way,the braid is able to expand longitudinally as the sections of the framemove away from each other during collapse. Substantially simultaneously,the graft material and the stent are reducing in diameter and staying ata similar angle to reduce the stress of fixedly attaching the graft tothe stent with a plurality of stitches. These figures also show oneexemplary embodiment of how the graft material 19310 is stitched to thestent lattice.

One exemplary embodiment of the graft for the heart valve assembliesdisclosed herein comprises nanofiber polyurethane spun into a braid-likeform back and forth on a central mandrel. The view of FIG. 195 is amicroscopic view of this graft as so fabricated when it is first laiddown and when no stretch is being imparted; in other words, the graft isin its natural state. FIGS. 196 and 197 are close-up views thatillustrate contact points between each nanofiber and show how thenanofibers adhere together. The braid angle of the graft is matched tothe angle of the central arms of the stent lattice so that, as thelattice transforms, the braid goes through a matching transformation.This means that, when the graft is stretched longitudinally, it reducesin diameter, so it behaves like a braided structure. FIG. 198 shows thegraft material when stretched in its length by 100%. FIG. 199 shows thegraft material returning to its natural state after being stretched inFIG. 198. The braid-like form is so tightly packed, fluid does not passthrough, therefore, the graft material is fluid-tight for purposes ofuse in blood vessels. An amount of polyurethane is added to thebraid-like form of this graft material. A minimal amount is addedthroughout the material but a heavier amount is used at the trimmed endsof the graft where the graft, when installed on the valve assembly,might be at risk of fraying.

It is noted that the various exemplary embodiments of the graftsub-assemblies described herein show the graft material on the inside ofthe lattice. Placing the graft material on the outside surface of thelattice is also envisioned. In such an exemplary embodiment, the exposeddrive screws are now covered and protected on one side by the graftmaterial and, if a valve assembly is present, on the other side by thevalve leaflets. Also the key-holes forming the bores for the drivescrews (see, e.g., FIGS. 156 to 160 and 204 to 209) are protected byplacing the graft material on the outside surfaces. An alternative toplacing the graft material on the outside surfaces to protect the drivescrews is a non-illustrated cover or sleeve that can be placed about thedrive screws. Such a cover can be, for example, corrugated orbellows-like or smooth or any other variation.

As the lattice enlarges circumferentially, the valve leaflets, which arefixed in size, change the size of the overlap at the downstream ends ofthe leaflets. It may be desirable to adjust the size of this overlap.Furthermore, the leaflet length is also a factor with regard tolongevity as undesirable wear can occur the more that the leafletcontacts any appreciably hard surface, including the stent lattice, thegraft material, the sutures, etc. Therefore, adjustment of the leafletsto minimize or prevent such contact is desirable. With theseembodiments, therefore, the leaflet size can be insured to maximizeorifice area while assuring coaptation of the leaflet edges but alsopreventing undesirable wear.

Accordingly, FIG. 200 shows an exemplary embodiment of a device thatadjusts the valve leaflet sub-assembly in the heart valve assembly. Inthis embodiment, the ends of the valve leaflets near the commisures arewound about a mandrel. If more overlap is desired, then the mandrel willbe spun in one direction and, if less overlap is desired, the mandrelwill be spun in the other direction.

FIG. 201 show another exemplary embodiment of an adjustable valveleaflet sub-assembly where each commisure has two mandrels for windingindividual ends of each leaflet. In this embodiment, each mandrel ofeach pair of mandrels is shown as having to wind in opposing directionsin order to take in the leaflets or let out the leaflets.

The view of FIGS. 202 and 203 show another exemplary embodiment of anadjustable valve leaflet sub-assembly of a heart valve assembly where alongitudinally moving adjustment shim 20300, when moved longitudinally(into or out from the view of FIG. 202), takes up more or lets out moreof the valve leaflet edge to shorten or lengthen the overlap portions ofthe valve leaflets.

In use, the exemplary adjustable valves described herein are deployedwith a minimal amount of released leaflet. This deployment configurationwill likely cause some amount of central regurgitation, assuming thatthe valve is sized to an amount above a minimum deployed diameter. Theleaflets are then released (played out) while monitoring with atransesophageal echocardiogram, for example. Once sufficient material isreleased to cause complete coaptation of the leaflets, the centralregurgitation will cease, which can be easily confirmed with TEE Dopplerevaluation.

FIG. 204 is another exemplary embodiment of aself-expanding/forcibly-expanding implantable stent assembly 20400. Incontrast to previously described lattices of the stent assemblies, thedistal and proximal jack struts 20412, 20414 of this embodiment have thewire-EDM jack screw bores machined from the outside surface of the stentassembly 20400. As shown in FIG. 205, the second connection part 14330contains the interior threads for threadingly mating with the exteriorthreads of the jack screw 14320 and the second connection parts 14330are staggered longitudinally about the circumference of the stentassembly 20400. As in previous exemplary embodiments, the firstconnection part 20615 at the distal jack strut has a T-shape and thesecond connection part 14330 is a nut having a cutout with an interiorshape corresponding to the exterior of the T-shape of the firstconnection part 20615. The beneficial difference between the wire-EDMjack bores being machined from the outside surface of the stent assembly20400 instead of the inside surface can be explained with regard toFIGS. 206, 207A, and 207B. In particular, if the cross-section of thedistal jack strut 20412 was square, then, when the T-shape is formed atthe proximal end for receiving the second connector part 14330 (the jacknut), there would be three spans of material connecting the proximal endto the remainder of the distal jack strut to provide three columns ofsupport therebetween, in particular, 20610, 20612, 20614. However, theouter cross-section of the distal jack strut is not square and, instead,is trapezoidal in order to allow the circular stent assembly to beconstricted to the smallest possible diameter as shown in FIG. 207.Thus, when the bore of the distal jack strut 20412 is machined from theinside surface (as shown in FIGS. 156 to 160 and 207) and the T-shape isformed at the proximal end 20615 for receiving the second connectionpart 14330, the first and second spans 20710, 20712 shrink to the pointof disappearing, depending on the depth of the groove for receiving thetongues of the interior of the second connection part 14330. In such acase, only the third span 20714 remains, which, in such a smallmanufactured part, allows for the possibility of deformation of theproximal end 20615 with respect to the remainder of the distal jackstrut 20412, which deformation is disadvantageous and could cause thejack screw(s) 14320 to malfunction or break. In comparison, when thejack bore is machined from the outside surface, as shown in FIG. 206,the two outer spans 20610, 20612 within the T-shape are large enough toremain because they are on the larger side of the trapezoid and,therefore, support the proximal end 20615 receiving the secondconnection part 14330.

FIG. 209 illustrates an exemplary embodiment of aself-expanding/forcibly-expanding implantable valve assembly 20900utilizing the lattice of the stent assembly of FIGS. 204 to 206. Here,both the valve sub-assembly 20950 and the valve graft sub-assembly 20960are connected using sutures 20970. Here, the upstream side of the valvesub-assembly 20950 (left in FIG. 209) is not connected at only itsupstream-most end at the upstream circumference of lattice arms 20902.In addition, a suture line 20972 is created that follows two separatearms 20904 of the lattice. With this suture line 20972, pockets 20962that might be created between the valve graft sub-assembly 20960 and thevalve sub-assembly 20950 are minimized and closed off to diastole flow.This suture line 20972 can be seen in the interior of the valvesub-assembly 20950 in the views of FIGS. 210 and 211.

Also shown in FIG. 209 is a sawtooth proximal edge 20964 of the valvegraft sub-assembly 20960 in addition to a sawtooth distal edge 20966. Bytrimming the proximal edge 20964, the possibility of obscuring either ofthe coronary arteries after implantation of the valve assembly 20900 isminimized. Also, having no graft material at the distal end decreasesthe overall amount of graft material, increasing the ability of thevalve assembly to collapse and increasing the ease of recapture withinthe delivery sheath.

As set forth above, this application is a continuation-in-part of U.S.Pat. No. 8,252,036, U.S. patent application Ser. Nos. 12/822,291,13/339,236, and 13/544,379, each of which have been incorporated herein.Described therein are various exemplary embodiments of aortic implants,including thoracic, abdominal, and valvular. Even though many of theexemplary embodiments of the stent lattices described herein aredescribed as stents or valve replacements, they are equally applicableto stent grafts for treating the thoracic and abdominal aorta, includingthe treatment of thoracic and abdominal aortic aneurysms, whether forjust the upstream end, the distal end, or both ends thereof. Thespecific incorporation of the exemplary stent lattices described hereininto the thoracic and abdominal applications, therefore, is not repeatedfor the sake of brevity but is to be construed as applying to each ofthe embodiments described in all related and parent applications.

FIGS. 212 to 217 illustrate a process for either unsheathing andexpanding a stent/valve assembly from the delivery sheath 10040, 10720,11040 or reducing and re-sheathing the stent/valve assembly back intothe delivery sheath 10040, 10720, 11040. Re-sheathing the stent/valveassembly is shown by the transition through all of these figuresstarting from FIG. 212 and ending at FIG. 217. Unsheathing thestent/valve assembly is shown by the transition through all of thesefigures in the reverse order starting from FIG. 217 and ending at FIG.212. In these figures, the nose cone and its catheter are notillustrated for clarity.

Beginning with a re-sheathing process, FIG. 212 shows an exemplaryembodiment of a valve assembly similar to the valve assemblies of FIGS.120, 143, 169, and 191 connected to the distal end of the deliverysystem with the valve assembly expanded for delivering the valveassembly with the delivery system in an implantation state. As thedelivery sheath 10040, 10720, 11040 is extended distally, the sheathentry device 21200 at the distal end of the delivery sheath 10040,10720, 11040 slides upon and over the disconnect coils 770. As thedelivery sheath 10040, 10720, 11040 is extended further, FIG. 213 showsthe sheath entry device 21200 partially re-sheathing thelattice-disconnector tubes 12630, 14340, 16940. Continuing there-sheathing process, FIG. 214 illustrates the valve assembly in anintermediate re-sheathing state where a proximal portion of the valveassembly, including the proximal jack struts 12012, 13314, 14314, 15514is re-sheathed. It is noted here that the outer radial corner of theproximal end of the proximal jack struts 12013, 13314, 14314, 15514 canbe chamfered in order to ease the entry of the proximal jack struts intothe delivery sheath. If a wire-EDM process is used to create the keyholebores for the drive screws as described herein, during the wire-EDMprocess of forming those key-holes, the outer radial corner of theproximal end of the proximal jack struts can be chamfered for the samereason. Further in the re-sheathing process, FIG. 215 shows the valveassembly re-sheathed half way across the exposed portions of the jackscrews 12020, 12620, 14320, 15520. FIG. 216 shows the re-sheathingprocess almost complete where the distal jack struts 12013, 13313,14313, 15513 are partially re-sheathed in the sheath entry device 21200.The re-sheathing process is complete in FIG. 217, where the valveassembly is entirely contained in the delivery sheath 10040, 10720,11040. At this point, the entire system can be removed from the patientor repositioned and, then, unsheathing at an improved implantation site.

It is noted that the sheath entry device 21200, as shown in FIG. 217, isslightly conical with the distal end slightly larger in area than theouter circumference of the delivery sheath 10040, 10720, 11040. It isnoted that this shape would be disadvantageous if in this orientationwhen the system is being extended up to the delivery site as providingthe delivery sheath with its smallest outer circumference is mostdesirable. In order to minimize the outer diameter of the sheath entrydevice 21200, the material of the sheath entry device 21200 is selectedso that the sheath entry device 21200 can be heat-shrunk or otherwisecollapsed. In one exemplary process for minimizing this outercircumferential diameter, the sheath entry device 21200 is shrunk aboutthe disconnect coils 770 as shown in FIG. 218. Thus, a maximum outercircumference of the sheath entry device 21200, even though it may begreater than 18 French, for example, can easily fit within an 18 Frenchorifice after be so processed. FIG. 219 shows the distal end of thesheath entry device 21200 after this process is performed but withoutall internal components of the delivery system and FIG. 220 shows thedistal end of the sheath entry device 21200 fully expanded afterretraction of the implant by the delivery system as explained above.

Unique aspects of the various embodiments of theself-expanding/forcibly-expanding implantable stent/valve assemblies ofthe present invention include an ability to better correspond withnatural geometry that is very different from prior art devices, whichonly expand to an ideal circular shape of an inflating balloon. FIGS.221 to 224 show the stent assembly of FIG. 191 expanding progressivelyinside an irregularly shaped mock-up implantation site that is hardenedso that the stent assembly does not move the mock-up from its irregularshape. As can be seen as the stent assembly expands, the mock-upimplantation site does not move and the stent assembly orients itselfautomatically to the particular irregular interior cross-sectional shapein which it is being implanted. As clearly shown in FIG. 224, the stentassembly is implanted within the irregular-shaped implantation site withlittle or no room between the lattice and interior walls of the mock-upimplantation site. Therefore, the invention can be used to conform toany shape, circumference, perimeter, diameter, cross-section, or othergeometric configuration in two or three dimensions.

One exemplary embodiment of a process for implanting any of thestent/valve assemblies described herein is described with reference tothe flow diagram FIG. 225. A handle, such as the one illustrated inFIGS. 108 to 118 and 226 to 230 includes a display 10814, 23010 andvarious user interface actuators 10816 and 23011 to 23017, such asbuttons. The following exemplary implantation process assumes that theuser interface actuators are seven in number, including a solid orange“center” button 23011, two retroflex buttons (flex 23012 and unflex23013), expand and contract buttons 23014, 23015, and extend and retractbuttons 23016, 23017. Additionally, the process flow steps shown in FIG.225 are exemplary display screens that occur at each stage of theimplantation procedure after a few preliminary steps have occurred.First, the system is opened from its dry package. The system can bepre-loaded with a stent assembly (e.g., 23 mm) at its native size andincludes a stent-loading funnel. Once the device is turned on, the firstscreen shows the status “Ready to Collapse” and gives the userinstructions on how to collapse with “Hold center button to collapse.”When the button is held, the drive screws move to collapse the stentassembly and, while the collapsing occurs, the screen of the display23010 indicates “release button to abort.” The display 23010 can show,simultaneously, a progress bar indicating the progress of stent assemblycollapsing. When fully collapsed by the system, the display 23010indicates that the user should now “Manually Collapse Stent” andindicates how this is accomplished by showing “Hold center to advancefunnel/sheath.” Moving of the sheath starts slow then moves faster. Asadvancing of the sheath/funnel occurs, the display 23010 indicates“Release Button to Abort.” The display 23010 simultaneously shows aprogress bar indicating how much sheathing is left. When sheathed, thedisplay shows “Sheathing Complete Remove Funnel” and the user removesthe sheathing funnel from the end of the delivery sheath. The display23010 shows that the next step can occur after the user “Hold[s the]center button to continue” and confirms that the funnel was removed. Thedisplay 23010 now indicates that the user should “Flush Stent” and toconfirm this flush by “Hold[ing the] center button to continue.” At thispoint, the “Device Ready for Patient” is displayed and the user isinstructed to “Hold center button to continue.”

Now the distal end of the device can be guided to the implantation site.If retroflexing is desired, then the display 23010 indicates that theLeft/Right buttons show retroflexing along with a progress bar. TheUp/Down buttons control sheath retraction. The display 23010 nowindicates that the user should “Hold down button to commit device” andindicates that the user should “Press center button to return toprevious screen” if not ready for implantation. The sheath is retractedslowly for the first half of the stent assembly with an option toreverse direction if desired. The display 23010 shows “RetractingSheath” and gives the user the direction to “Release button to abort.”If desired, the button can be held for full sheath retraction along witha displayed countdown to full retraction. The device takes up play inthe drive screws and presents the stent assembly in a pre-definedposition and/or a native position. For example, the stent assembly canbe expanded to 15 mm in diameter and progress bars can indicate statusof stent assembly along with showing diameter with a circle that is thesame diameter as the stent assembly. When done, the display indicates“Sheath Fully Retracted” and the user should “Hold center button tocontinue.”

Now, the stent assembly is ready for implantation. Both radial force andthe diameter of the stent assembly can be displayed along with progressbars if desired. The diameter can be indicated with a circle that is thesame diameter of the stent assembly. Any of the buttons can be used tolimit the maximum radial force that is desired by the user and thedisplay 23010 can show, with a status bar, a radial force limitindicator. The software can account for the loads required to expand thestent lattice and the friction loads of the drive system so that anaccurate representation of the force being imparted to the tissue can becommunicated to the user, for example, in pounds/kg. Given thetime-dependent nature of tissue's reaction to load, the software cancontinue to apply a known target force to the tissue for a period oftime after initially meeting the load. As the tissue remodels, the stentlattice will continue to expand and continue to apply the target forceup to the maximum limit of the lattice's circumference. The software cantrack the response of the tissue and, once the rate of change ofexpansion declines below a threshold, it can stop expansion of the stentlattice. In an alternative embodiment, all expansion of the implant canoccur synchronized with the heart's contractions to coincide with anyparticular portion of the sinus rhythm. Diameter control buttons 23014,23015 are used to control the diameter, which, for this example, startsat 15 mm. Each press of a button can cause, for example, a 0.5 mmincrement or decrement of the stent assembly along with showing thediameter in millimeters and/or with a circle of the same diameter. At apoint where the nominal radial force detected from the implant hasstabilized, the display 23010 can indicate to the user that a firstangiogram or ultrasound (for example) should be carried out to see ifany paravalvular leak exists. If a leak exists, the user can increasethe target force level up to the maximum that the implant can take asdesigned and further or re-expand with the same rate of change detectionrepeated until paravalvular leaks are sealed or maximum expansion of thestent lattice results. If the latter occurs, the user will be notifiedif the radial force measured will be sufficient to prevent embolizationof the implant if deployed as implanted. If not, the user will beadvised or prevented from deploying the implant. When ready to implant,one of the buttons lights green (e.g., the center button 23011) toindicate that pressing that button will disconnect the implant from thedelivery system. To perform the disconnect, the user holds the buttonfor a period of time (e.g., five seconds), during which time the buttonflashes and the handle produced an audio indicating the automateddisconnect sequence is about to begin. When first pressed, the display21010 shows “Disconnecting” along with a countdown number for seconds todisconnect. At the end of the countdown, the automated disconnectsequence starts. One step in this sequence is to remove any wind up thathas been built up in the drive screw wires. This can be done in one oftwo ways. A first way to perform wind up release is to reverse the drivemotor with a low level of torque sufficient to remove wind up but notsufficient to create additional reverse wind up or drive the screws inreverse. Alternatively, by having known the last input torque, a look-uptable can be accessed that contains the fixed number of turns that arerequired to remove the wind up associated with that torque. At the endof the automated disconnect sequence, the disconnect wires 770 arewithdrawn from the drive screw coupler parts 14652, 14654 to completedisconnection of the implant.

When disconnected, the display shows “Disconnected” and directs the userto “Hold center button to continue.” Any retroflex can be released andthe user is shown that the device is “Ready to Re-Sheath” the distalparts of the delivery system into the delivery sheath and is shown that,to do so, the user must “Hold center button to re-sheath.” With thatbutton press, the display 23010 shows that “Re-Sheath” is occurring andthat the user can “Release button to abort” the re-sheathing of thedelivery components. When the exposed parts of the delivery system aresafely located in the delivery sheath, the display indicates “DeviceTerminated” and, therefore, the delivery sheath is “Ready to remove frompatient.”

Another exemplary embodiment of a delivery system control handle isshown in FIGS. 226 to 230. The housing of the delivery system controlhandle 22600 is, in this exemplary embodiment, a clam-shell having topand bottom halves. The top half of the housing contains most of theelectronic elements, including the electronic control circuitry, thedisplay, and user control buttons (see FIGS. 229 and 230). The bottomhalf of the housing contains most of the mechanical elements. Regardingthe latter, a grounding base 22610 is fixedly connected to the bottomhalf of the housing. This forms the ground for most of the mechanicalcomponents.

First, a retroflex support tube 22710 is secured at its proximal end tothe grounding base 22610. The retroflex support tube 22710 surrounds amultilumen shaft 22630 having lumens therethrough for all control andguide wires. In this exemplary embodiment, the number of lumens is ninein total. Not illustrated is a distal retroflex knee fixedly attached tothe distal end of the retroflex support tube 22710 about the multilumenshaft 22630. The knee is cylindrical in shape and has slits along onelateral side thereof. Also attached to the distal end of the knee is adistal end of a retroflex wire 22622. The proximal end of the retroflexwire 22622 is attached translatably within a retroflex trolley 22624.When the retroflex trolley 22624 translates proximally, retroflex of thedistal end of the delivery system occurs. It is desirable to allowphysical flexing or retroflexing of the distal end of the deliverysystem without use of the retroflex trolley 22624. Accordingly, theretroflex wire 22622 has a non-illustrated collar connected within aslot of the retroflex trolley 22624 that is free to move proximally butconstrained to move distally within the slot. Thus, if a bend in thedelivery sheath causes tension in the retroflex wire 22622, that wire isfree to move proximally through the retroflex trolley 22624. Movement ofthe retroflex trolley 22624 upon a retroflex guide pin 22625 is causedby interaction of the retroflex trolley 22624 with rotation of aretroflex shaft 22626, for example, by a follower nut, a cam, or othersimilar connection that allows the retroflex trolley 22624 to translatelongitudinally as the retroflex shaft 22626 rotates. Rotation of theretroflex shaft 22626 is controlled by a retroflex motor 22628.

The delivery sheath 11040 is coaxial with and surrounds the retroflexsupport tube 22710. The proximal end of the delivery sheath 11040 isfixed to a sheath trolley 22744, which rides along a sheath guide pin22746 based on movement caused by rotation of a sheath drive screw22748. Interaction of the sheath trolley 22744 occurs with rotation of asheath drive screw 22748, for example, by a follower nut, a cam, orother similar connection that allows the sheath trolley 22744 totranslate longitudinally as the sheath drive screw 22748 rotates.Rotation of the sheath drive screw 22748 is controlled by a sheath motor22749. Because the sheath guide pin 22746 is fixed to the grounding base22610, translation of the sheath trolley 22744 causes distal or proximaltranslation of the delivery sheath 11040 with respect to the controlhandle 22600.

It is desirable to have the entire distal delivery portion of theimplant and the implant (as shown for example in FIGS. 105, 107, and 169to 173) translate longitudinally when at the implantation site. But, itis not simply desirable to have the user control that longitudinalplacement. Once the implant is near the implantation site, it would bedesirable to fix the control handle 22600 with respect to the patientand mechanically extend and/or retract the implant for best positioning.However, because the drive wires 750 for turning the jack screws and thedisconnect drive wires connected to the puck control screws 17032 fortranslating the puck 17020 and thereby the disconnect wires 770 must berotated from within the handle, translation of those elements requirestranslation of at least the transmission imparting such rotation, if notalso translation of the respective motors. The control handle 22600provides such translation of both the motors and the respectivetransmissions. In particular, a translation ground 22800 is fixedlyconnected to the control handle 22600. The translation ground 22800 hasa threaded bore that guides a translation drive screw 22810 therein. Thetranslation drive screw 22810 is fixedly connected at one end to atransmission of a non-illustrated translation motor (located under aself-contained motor/transmission sub-assembly 22820. The translationmotor rotates the translation drive screw 22810 when actuated and isalso fixed to the control handle 22600. The motor/transmissionsub-assembly 22820 is translationally associated with the translationdrive screw 22810 such that the entire motor/transmission sub-assembly22820 translates longitudinally when the translation drive screw 22810rotates. For example, under the motor/transmission sub-assembly 22820 isa bracket attached thereto and having a threaded bore receiving thereinthe translation drive screw 22810 such that, when the translation drivescrew 22810 rotates, the bracket with the motor/transmissionsub-assembly 22820 translates. Within the motor/transmissionsub-assembly 22820 are all of the motors and/or transmissions forrotating each of the, for example, six drive wires 750 for the drivescrews (whether in groups or individually) and for rotating each of the,for example, two disconnect drive wires 22840, 22842. At the other endof the translation drive screw 22810 is a multilumen ground 22830 fixedto the proximal end of the multilumen shaft 22630. Like themotor/transmission sub-assembly 22820, the multilumen ground 22830 has athreaded bore shaped to fit therewithin the translation drive screw22810. In such a configuration, any rotation of the translation drivescrew 22810 simultaneously and synchronously moves the multilumen ground22830 and the motor/transmission sub-assembly 22820 together, all thewhile keeping the two separated by a fixed distance. In this way,translation of the implant with respect to the control handle 22600 andthe delivery sheath 11040 can be effected, for example, by thepositioning buttons 23016, 23017 located on the side of the controlhandle. Such positioning can be analog and smooth without any particularsteps or it can be programmable to move a given fixed distance everytime one of these buttons 23016, 23017 is pressed.

The exemplary embodiments of the valve assemblies described herein seekto have a valve that is sized and formed for a minimum deploymentdiameter. This valve is secured inside the stent lattice/frame that iscapable of expanding to a much larger final diameter than the internalvalve. The commisures of the valve are secured to the frame with amechanical linkage that allows the frame to expand and keep the valve ata proper size to minimize regurgitation. A lower skirt of the valve isattached to the stent through a loose connection of the variablediameter braided graft or a similar device. This configuration allowsthe stent frame to continue to grow and fit into a variety of nativeannuli that are larger than the valve carried within the device.

Even though the exemplary embodiments shown above relate primarilytowards an aortic valve, these embodiments are not limited thereto. Asstated before, the invention is equally applicable to pulmonary, mitraland tricuspid valves. Additionally, the invention is equally usable inany tubular anatomic structure, some embodiments of which will bedisclosed herein.

Known to surgeons, physicians, and biomedical engineering and medicalpersonnel is that, with regard to devices to be implanted in a tubularor hollow structure, whether for expanding (e.g., angioplasty), foroccluding, for wall patency (e.g., stents, stent grafts), or forreplacing a physical structure (e.g., replacement valve), sizemismatches lead to problems. Simply put, sizing symmetrical devices tomatch non-ideal anatomy is an issue in medicine. Where the surgeon hasno way to control the prior art devices, implantation flaws and acertain amount of para-device leaking just must be accepted. Real-timefeedback (the elements of which are integrated to the platform, thedelivery system, the device itself, or a combination thereof) of theseflaws, imperfections, and or leaks would be beneficial for currentprocedures but are simply not available for, for example,balloon-installed or self-expanding devices. Significant to theembodiments disclosed and equally applicable to other tubular structuresor orifices, the self-expanding and forcibly-expanding exemplarylattices described herein in contrast to the prior art has absolutecontrollability, allowing it to become a platform for many procedures,operations, and/or anatomies. As described herein, the various deviceshave actuatable geometry on all or specific locations of the device inwhich the self-expanding and forcibly-expanding exemplary lattice isused.

With regard to other structures of the heart, for example, the describedembodiments are applicable to mitral valve replacement or repair. Themitral valve annulus is more pliable than the aortic valve annulus. Itis also very close to the atrioventricular (AV) groove and the fibroustrigone (the thickened area of tissue between the aortic ring and theatrioventricular ring), which can be damaged when dealing with themitral valve. The mitral valve also has significant sensitivity to bothsizing and radial force. Undersizing of an implant causes leaks andembolization. Oversizing of the implant causes damage to the heart, notjust by tearing the valve seat but also by changing the overall geometryof the left ventricle, rendering the heart less efficient for cardiaccycling. Accordingly, precise attachment and fine adjustment to theanatomy is needed, which is easily accomplished by the embodimentsdisclosed. Adjustability of the self-expanding and forcibly-expandinglattices of the described embodiments allows for precise and concomitantsizing and sealing, the significant issues associated with mitral valvereplacement or repair. Additionally, the self-expanding andforcibly-expanding lattices described herein can be modified for mitralvalve replacement to be D-shaped as an alternative to the circularshapes described herein such that a portion of the circumference isexpandable (and contractable) and another portion remains constant(i.e., the flat of the D-shape). The self-expanding andforcibly-expanding lattice gives precise sizing and imparts a preciseand controllable force to reduce damage and create a near-perfect seal.In mitral valve repair, modulation of the mitral valve annulus is thecornerstone of annuloplasty. In this exemplary embodiment, the devicecan be fixed to the mitral valve annulus directly, percutaneously, orminimal invasively, the implanted device being actuatable to change allor portions of the shape, diameter, perimeter, or overall configurationor a combination thereof to achieve proper coaptation of the nativemitral valve leaflets. Other embodiments allow concomitant orindependent actuation of the mitral sub-valvular apparatus. In yet otherembodiments, this device can effect mitral valve repair by placementwithin the coronary sinus or epicardially in plane with the mitralannulus allowing for similar actuation of the native mitral annulus.Adjustability of the self-expanding and forcibly-expanding lattice,therefore, resolves both the issues of sizing and radial force. Anothernotable item is that the mitral valve has an axis that is very offsetfrom the entrance vector during operation. Therefore, the device must bevery steerable. The swashplate embodiments described herein, forexample, aid in replacement of the mitral valve even where placementtolerance is very narrow.

Likewise, the described embodiments are applicable to tricuspid valvereplacement or repair. All of the features described above for themitral valve are equally applicable for the tricuspid valve replacementor repair and, therefore, they are not repeated for reasons of brevity.In recent times, there has been an increase in tricuspid valve disease.Significant to tricuspid valve disease is that the patients are“high-risk”; they are very sick when the disease has progressed enoughfor the patient to show symptoms. With regard to the tricuspid valve, itis close to the conduction region of the heart. Currently, tricuspidvalve disease is repaired with a split ring so that the conductionregion is not injured in any way. In comparison to the mitral valve, theaxis of the tricuspid valve is ninety (90) degrees offset from the venacava. Therefore, significant steerability is needed. The radial forcethat can be imparted is also limited in tricuspid valve replacement orrepair. In particular, the maximum radial force that can be imparted islimited due to the proximity of the heart's conduction system.Accordingly, precise attachment and fine adjustment to the anatomy isneeded, which is easily accomplished by the embodiments disclosed. Theadjustability of the self-expanding and forcibly-expanding lattice ofthe embodiments allows for precise and concomitant sizing and sealing,the significant issues associated with tricuspid valve replacement orrepair. The self-expanding and forcibly-expanding lattice gives precisesizing and imparts a precise and controllable force to reduce damage andcreate a near-perfect seal. Adjustability of the self-expanding andforcibly-expanding lattice, therefore, resolves both the issues ofsizing and radial force. Like the mitral valve repair or replacement theswashplate embodiments, for example, can be used to aid in replacementof the tricuspid valve even where placement tolerance is very narrow.

The described embodiments are applicable also to pulmonic valvereplacement or repair. The adjustability of the self-expanding andforcibly-expanding lattice of the embodiments allows is an importantadvantage with regard to pulmonic valves. This is because disease of thepulmonic valve is often congenital and, therefore, commonly presents inchildhood. For Pulmonic Atresia, for example, the pulmonic valve becomesnarrow and muscular. Therefore, not only must the surgeon replace thevalve, but the surgeon must also replace some or all of tract for thepulmonic valve. The most significant problem with pulmonic valve diseaseis that the typical patient keeps growing after the first operation.Typically, each patient has four to six (4-6) operations during his orher life. This is because, as the patient grows, a larger and largervalve needs to be provided. Each of these surgeries has its ownassociated risks, but multiple surgeries just compound those risks.

In contrast to the prior art, the embodiments of the self-expanding andforcibly-expanding lattice described entirely eliminate surgeries afterthe first valve implantation. In particular, instead of performing opensurgery on the patient for the second and subsequent surgeries, theadjustable self-expanding and forcibly-expanding lattices describedherein are able to be enlarged percutaneously by simply re-docking anadjustment device to a portion of the implant's structural platform (forexample, one or more jack screws) and further expanding the lattice toaccommodate the growth of the patient. Not only does this savesignificant costs by virtually eliminating the most costly parts of thesubsequent surgeries, the non-invasive expansion greatly decreases theprobability of injury caused by such open surgeries.

The self-expanding and forcibly-expanding lattice embodiments describedherein have been mostly cylindrical for purposes of clarity and brevity.They are not limited to this configuration, however. As shown, forexample, in FIG. 155, variations to the outer shape of theself-expanding and forcibly-expanding lattices, here the lattice beinghourglass-shaped, cause different and procedure-dependent improvementsin the efficacy of the implant. Other shapes having geometries dependingupon the implant location, including half of an hourglass, tapering,curving, and other geometries, are equally suitable for creating a sealand retention in other anatomical location. In another exemplaryembodiment, an implant 23100 has a self-expanding and forcibly-expandingcentral lattice 23102. One or both of the open ends of the lattice 23102(here, both ends) have a self-expanding, conical stent structure 23104,23106 outwardly expanding away from the central lattice 23102. In theexemplary embodiment shown, all ends, including the non-moving strut23116 and the two parts of the moving strut (the distal jack strut 23113and the proximal jack strut 23114), extend longitudinally with respectto the implant 23100. These extended ends are curved outward to form thehourglass shape. Depending on the desired configuration of the distaland proximal ends of the implant 23100, any combination of extensions ispossible. Some exemplary configurations include: both ends of only thenon-moving strut 23116 extending longitudinally; only one end of thenon-moving strut 23116 extending longitudinally; only the distal jackstrut 23113 extending longitudinally; only the proximal jack strut 23114extending longitudinally; and both the distal jack strut 23113 and thejack strut 23114 extending longitudinally. The illustrated exemplaryembodiment also shows extensions 23123, 23124 of the distal and proximaljack struts 23113, 23114 shorter than the extension 23126 of thenon-moving strut 23116. The lengths of the extensions 23123, 23124,23126 can be the same or reversed to the configuration shown. Forexample, because the central lattice 23102 will shorten longitudinallywhen expanded, the length of the extensions 23123, 23124 of the distaland proximal jack struts 23113, 23114 can be longer than the extension23126 of the non-moving strut 23116 so that, when circumferentiallyexpanded to the desired size for implantation, all of the ends of theextensions 23123, 23124, 23126 are substantially aligned along a singlecircumferential plane perpendicular to the longitudinal axis of theimplant 23100. While the surgeon may not be able to know the exactimplantation diameter/perimeter/shape that would correspond to aparticular geometry of the patient's implantation site, pre-surgerymeasurement (e.g., by trans-esophageal echocardiogram, CT scan, MRI,intra-cardiac echocardiogram, nuclear scanning, or fluoroscopicvisualization) could provide the surgeon with enough information toselect an implant 23100 having extensions 23123, 23124, 23126 that willbe substantially aligned about a given circumference when expanded tothe pre-measured geometry in the patient. Thus, before surgery, thesurgeon measures the diameter of the implant desired and selects oneimplant 23100 from a set of differently sized implants 23100. Slightlylarger or smaller expansion of the central lattice 23102 with respect tothe measured diameter, therefore, only means that the ends of theextensions 23123, 23124, 23126 do not reside in the same circumferentialplane. As geometry of an implantation site is irregular, it isenvisioned that such an ideal configuration of ends in a single planewill be difficult to achieve even with a perfectly symmetrical device.

Between the extensions 23123, 23124, 23126 of the distal and proximalends 23104, 23106 are intermediate arms or webs 23128 that connectadjacent pairs of extensions 23123-23126, 23124-23126 in any waydesired. Here, the intermediate webs 23128 circumferentially connectadjacent pairs of extensions 23123-23126, 23124-23126 approximately atthe midpoint of the extensions 23123, 23124, 23126 and at approximatelythe endpoints of the extensions 23123, 23124, 23126. This, however, ismerely one exemplary embodiment and more or less webs 23128 can be usedwith any geometry, with any angle, and with any length. For example, thewebs 23128 can follow the angles of the arms of the stent lattice 23102.

FIGS. 232 and 233 show, respectively, the implant 23100 before it iscompletely implanted in a heart valve 23201 and in a vessel 23301. InFIG. 232, the central lattice 23102 is partially expanded to startcollapsing the diseased leaflets of the patient's valve 23201, but thedistal and proximal ends 23104, 23106 have not yet touched the walls oneither side of the valve 23201. In contrast, in FIG. 233, the centrallattice 23102 is partially expanded but still not touching the walls ofthe diseased vessel 23301. The distal and proximal ends 23104, 23106 ofthe implant in FIG. 233, however, have already touched the vessel walls.In this configuration, connection of the ends to the wall of the vessel23301 before connection of the central lattice 23102 occurs preventsshuttling of the implant 23100 while the central lattice 23102 continuesto expand to the desired implantation circumference, which can beapproximately equal to, smaller than, or greater than the diameter 23302of the vessel 23301.

The ends 23104, 23106 of the central lattice 23102 or attached to thecentral lattice 23102 can be made of a shape-memory material such asNitinol that is integral or connected to (e.g., fused) the centrallattice 23102. These ends 23104, 23106 can also be configured in variousshapes. In FIG. 231, each end 23104, 23016 is shown as being anexponentially increasing expanding cone. Alternative shapes, somedescribed below, can include the shape of a barbell, such as the distalend 23402 of the implant 23400, or the shape of a bulb, such as thedistal end 23504 of the implant 23500. The two ends of a self-expandingand forcibly-expanding implant can be identical or different, dependingon the requirements of the particular implant. In each case, theseextensions have a given final memory shape to suit the particularsurgical procedure being conducted. When captured in the deliverysheath, as in other self-expanding memory-shape devices, the endscompress radially inward to permit loading into a delivery catheter.When allowed to release therefrom, the ends expand to the pre-definedmemory shape (which can be constrained partially if the self-expandingand forcibly-expanding portion of the implant is not yet forciblyexpanded to allow the self-expanding end(s) to completely self-expand.

The hourglass shape is particularly suited for various surgicalapplications where acute retention to prevent shuttling in the anatomyis desired. Not only is this shape beneficial for replacement of allvalves of the heart, it is also advantageous in procedures treating, forexample, atrial septal defects (ASD), ventricular septal defects (VSD),patent ductus arteriosis (PDA), ventricular aneurysms, patent foramenovale (PFO), arteriovenous fistulae, paravalvular leaks, and left atrialappendage (LAA) ligation, and in performing embolization and angioplastyof vessels. Each of these procedures and conditions benefit from havingself-expanding flares that establish the geometry of the anatomy and theself-expanding and forcibly-expanding central platform that preciselyadjusts the waist between the flared ends. Even though an hourglassshape as described herein might be used for these procedures for variousreasons, they are not described herein as being limited to and any ofthe implant shapes are equally applicable to any of the exemplarysurgical procedures described herein.

Depending on the procedure being performed, the implant can be coveredby different polymers or by a matrix or mesh of material. The coveringcan be semi-porous for sealing over time with cellular in-growth and/orit can have portions that are non-porous to seal immediately uponimplantation or even just before implantation. A non-porous coveringover the entirety is also contemplated. The covering can be external orinternal or both, and can be located anywhere on the implant includingthe distal side, the central lattice, the proximal side, and even withinthe central orifice of the implant at any longitudinal position withinthe lumen to occlude the lumen and prevent flow through the lumen. Forexample, an occlusion curtain can be disposed within the cross-sectionof the central orifice, in particular, within the waist, dependent onthe effect that is desired. It can be beneficial if the material used isdistensible so that it does not corrugate or pleat but, in particularcircumstances, it can be non-distensible.

An atrial septal defect (ASD) is a form of congenital heart defect thatenables blood flow between two compartments of the heart—the left andright atria. Normally, the right and left atria are separated by theinteratrial septum 23610. If this septum is defective or absent, thenoxygen-rich blood can flow directly from the left side of the heart tomix with the oxygen-poor blood in the right side of the heart, or viceversa. Another potentially fatal consequence of an ASD is that bloodclots are able to pass through the ASD and, instead of going to thelungs, where a clot might be harmless and dissolve over time, such clotstravel to the brain, which can cause stroke and, in some instances,death.

During development of the fetus, the interatrial septum develops toseparate the left and right atria. However, during early fetaldevelopment, a hole in the septum called the foramen ovale, naturallyallows blood from the right atrium to enter the left atrium. Thisopening allows blood to bypass the nonfunctional fetal lungs while thefetus obtains its oxygen from the placenta. A layer of tissue called theseptum primum acts as a valve over the foramen ovale during fetaldevelopment. After birth, the pressure in the right side of the heartdrops as the lungs open and begin working, causing the foramen ovale toclose entirely. In approximately twenty five percent (25%) of adults,the foramen ovale does not entirely seal. In these cases, any elevationof the pressure in the pulmonary circulatory system (due to pulmonaryhypertension, temporarily while coughing, etc.) can cause the foramenovale to remain open. This is known as a patent foramen ovale (PFO), atype of ASD.

One device for treating ASD currently is H-shaped. When inserted intothe ASD orifice, the device expands and blocks both sides of the septumwith two opposing plates, one on each side of the defect. These plates,however, are much larger than the defect. This is disadvantageousbecause the device places a large mass inside the atrium, decreasingatrial volume. Further, the cylindrical central connection of the twoplates is not sized to fill the defect, thus, unless seal is completeacross the ASD, blood can still traverse the ASD. Also disadvantageousis the fact that these plates require significant overlap to insure aseal of the defect; in other words, they are larger than the diameter ofthe ASD orifice.

The hourglass-shaped, self-expanding and forcibly-expanding implant ofthe embodiments described herein provides significant advantages overprior art devices and treatments. First, the precisely actuatable waistis able to be expanded to match the size of the defect without imposingexcessive and/or uncontrollable outward force on the wall edges of thedefect. Second, the implant includes an internal, central, solid mass,curtain, or plate to prevent blood cross-over, this curtain is only asthin as it needs to be to last and adds no volume to either atria. Thematerial of the curtain can be human tissue or it can be other mammaliantissue or a natural or synthetic fabric. The curtain can even besemiporous to create a natural, endothelialized wall after the implanthas been in the defect for a while. The implant is flared into thehourglass shape on both sides to prevent migration. FIG. 236 illustratesa heart with an ASD and FIG. 237 illustrates this defect repaired withsuch a self-expanding and forcibly-expanding implant 23700. In somecircumstances, the seal may breakdown and later re-adjustment and/orrepositioning may be required.

Because implantation of the self-expanding and forcibly-expanding deviceis less invasive, it can be used more often to treat ASDs becauseaccessing the superior vena cava is performed with an endovascularprocedure and not open surgery. For example, it is believed that ASDsare one cause of migraines, due to the ASD allowing flow from the rightatrium to be directed into the brain. The self-expanding andforcibly-expanding implant can treat such conditions. While VSDs occurless frequently than ASDs, VSDs can be treated in the same way as ASDsas described above.

The ductus arteriosus is a normal fetal blood vessel that closes soonafter birth. Patent ductus arteriosus (PDA) is a congenital disorder inthe heart wherein a neonate's ductus arteriosus fails to close afterbirth. In a PDA, the failure of the vessel to close results in anirregular transmission of blood between two of the most importantarteries close to the heart, the aorta and the pulmonary artery.Specifically, a PDA allows a portion of the oxygenated blood from theleft heart to flow back to the lungs by permitting flow from the aorta(which has higher pressure) into the pulmonary artery. Thehourglass-shaped, self-expanding and forcibly-expanding device can beimplanted inside the ductus arteriosus to close off the connection usinga curtain within the lumen of the implant. One exemplary configurationof an internal curtain can be explained with regard to FIG. 232, 233, or237. The inside lumen of the central lattice 23102 on one side of thejack screws 23113 (e.g., the distal side) is covered with a materialthat can expand along with the lattice 23102. The single sheet ofmaterial is connected to most or all of the distal struts 23113 and thenon-moving struts 23116. If the material around and inside the implantis semiporous, natural ingrowth about the implant occurs, causing theimplant to be completely covered and forming part of the atrial wall.

An arteriovenous fistula is an abnormal connection or passageway betweenan artery and a vein. It may be congenital, surgically created forhemodialysis treatments, or acquired due to pathologic process, such astrauma or erosion of an arterial aneurysm. These passageways, which mayoccur anywhere in the body including the brain or spinal cord, act likea short circuit diverting blood from fully circulating and deliveringoxygen where it is needed. The hourglass-shaped, self-expanding andforcibly-expanding device can be implanted inside the arteriovenousfistula to close off the connection using a curtain within the lumen ofthe implant. The configuration illustrated in FIG. 232, 233, or 237 canform an example of a self-expanding and forcibly-expanding device thatis covered about the exterior or interior and has an internal curtainwithin the lumen and is implanted in an arteriovenous fistula betweenthe two vessels. If the material around and inside the implant issemiporous, natural ingrowth about the implant occurs, causing theimplant to be completely covered and forming a new intermediate vesselwall.

While the cylindrical self-expanding and forcibly-expanding device canbe used in vessels and other similarly shaped anatomy, in somecircumstances, it may be desirable to use, instead, thehourglass-shaped, self-expanding and forcibly-expanding device. One sucharea includes embolization and angioplasty of vessels. Embolization is aminimally invasive treatment that occludes, or blocks, one or more bloodvessels or vascular channels of malformations (abnormalities). In acatheter embolization procedure, medications or synthetic materials areplaced through a catheter into a blood vessel to prevent blood flow tothe area. Catheter embolization is performed, for example, to control orprevent abnormal bleeding. This includes bleeding that results from aninjury, tumor, or gastrointestinal tract lesions such as ulcer ordiverticular disease. Embolization is commonly the first line oftreatment in gastrointestinal bleeding of any cause. Controllingbleeding into the abdomen or pelvis from injuries caused in a motorvehicle crash is especially suitable for this treatment. Catheterembolization is also performed to occlude or close off the vessels thatare supplying blood to a tumor, especially when the tumor is difficultor impossible to remove, such as a brain tumor. After embolization, atumor may shrink or it may continue to grow but more slowly, makingchemotherapy or surgery a more effective option. There exist manyprocedures in which a surgeon intervenes at a particular anatomy to usea catheter to access a vein/artery and strategically close it. Forexample, in a trauma situation such as a stab of a spleen or a liver.With regard to the latter, the right lobe of the liver can survive whenflow to the left lobe of the liver is occluded. Where a patient iscoughing blood, embolization can be used in a pulmonary artery. In eachof these situations, the hourglass-shaped, self-expanding andforcibly-expanding device can be placed as shown, for example, in FIG.233. With an exterior or interior covering along the peripheral cylinderand an appropriately placed internal curtain closing off the centrallumen of the device, when implanted, the anatomy can be securely andremovably occluded.

The inventive designs can also be used in other areas, such as the leftatrial appendage. In current procedures for ligating the LAA, a devicereferred to as the WATCHMAN® is used. There exist significantdisadvantages with such a device. Prior to implantation, the surgeonneeds to measure the internal volume of the LAA, which is very hard todo because the LAA is a very compliant and soft structure. Thus,presizing is difficult. The LAA is typically not under pressure duringsizing. Accordingly, problems occur with finding an accurate terminaldiameter of the implant when the LAA is under pressure later caused bythe device. Current treatment technology comes in certain sizes, one ofwhich needing to be selected for the surgery. The current devices arehard to install due to the volumetric and shape mismatch. If a device istoo small, then a space around the device occurs after implantation,making the space(s) ripe for undesirable clotting. With insufficientvolume mismatch, existing clots in the LAA can be dislodged, which isdangerous as those clots will immediately enter the aorta. On the otherhand, if the sized device is too large, implantation can cause acutetraumatic disruption, requiring emergency surgery or even causing death.Additionally, even if the prior art device is successfully implanted,which is shown in FIGS. 238 and 239, if that device places too muchforce within the LAA, it will erode the wall, ultimately causing arupture, with the resulting negative consequences. It is known that theLAA varies substantially in thickness along the appendage and some areasare so thin that a surgeon can see right through the wall. Accordingly,ruptures are likely when implants connect with that part of the wall.

Once a surgeon implants a device to treat the LAA, it is desirable tofill the space as much as possible but to not leave a volume that allowsblood to enter, to exit, and/or to clot. If one is able to close thespace within the LAA and seal the orifice as well, then this couldeliminate any possibility of clot dislodgement. It would be, therefore,advantageous to be able to expand a device intermittently usingvisulation (e.g., by continuous fluoroscopy or echocardiogram) untilcomplete occlusion/isolation of LAA from general circulation occurs, atwhich time, the surgeon would stop expanding the device. However,current devices are substantially circular and only fill LAAvolumetrically; they are not intended to seal the atrial-appendagejunction. Thus, current devices cannot both take up the volume and sealthe orifice. Additionally, current devices cannot be expandedintermittently because they are all self-expanding—they either remaincontracted before removal from the delivery catheter or expandcompletely all at once when the delivery catheter is removed.

All of these disadvantages of the prior art are resolved by theself-expanding and forcibly-expanding devices described herein becausethese devices can both fill the volume of the LAA and, at the same time,create a seal at the atrial-appendage junction. FIG. 240 illustrates oneexemplary embodiment of a device 24000 for treating the LAA. As before,the self-expanding and forcibly-expanding lattice 24002 forms thecentral portion of the device 24000. Extending distally from the distalend of the device 24000 is a bulb-shaped self-expanding extension 24004.Opposite the bulb extension 24004 is a self-expanding barbell extension24006. Together, these two extensions 24004, 24006 work to fill thevolume when the device 24000 is implanted. Sealing of the LAA occurs byplacement of one or more curtains within the lumen of the device 24000.For example, if an occluding curtain is disposed within the lattice24002 at the dashed line 24040, then, when the lattice 24002 is expandedwithin the atrial-appendage junction 24022 and the barbell extension isallowed to self expand at the LAA entrance, the interior of the LAA isshut off from the left atrium. Another possibility includes the curtainextending proximally into the barbell extension along the wall of thebarbell extension and to the outer extremity thereof. Likewise, thecurtain can extend distally into the extension 24004. If the interiorcatheter needs to pass through the curtain, then a valve is integral tothe curtain which seals after withdrawal of the catheter or the materialis self-healing to close after implantation. The curtain can also be aseparately implanted device that expands into the lumen of the device toocclude the lumen after implantation of the device.

An exemplary procedure for ligating the LAA with the device 24000 startswith placing a guidewire into the left atrium 24010. The guidewire is,then, threaded into the LAA. The device 24000 is driven over theguidewire until the distal end enters the LAA cavity 24020. In itsnatural state, the LAA is floppy and bends from approximately ninety toapproximately one-hundred and eighty degrees. The device 24000 isinserted sufficiently into the LAA cavity 24020 to place the distal bulbextension 24004 within the cavity 24020, the central lattice 24002within the LAA orifice at the atrial-appendage junction 24022, and thebarbell extension 24006 just proximal of the atrial-appendage junction24022. In such a configuration, as shown in FIG. 240, when expanded, thedevice 24000 can both fill the LAA volumetrically and create a seal atthe atrial-appendage junction 24022. The delivery catheter 24030 isretracted from the device 24000 to allow self-expansion of the device24000 to a pre-set state, which, for example, can be the state shown inFIG. 240. The central lattice 24002 is set with a self-expansiondiameter smaller than the diameter of the orifice at theatrial-appendage junction 24022. The distal bulb extension 24004 ispartially self-expanded at this point because the lack of completeexpansion of the central lattice 24002 prevents the bulb extension 24004from self-expanding entirely. Alternatively, the bulb extension 24004can be pre-set to be at full self-expansion when the central lattice24002 is at its self-expanded and not-yet-forcibly-expanded state.Similarly, the proximal barbell extension 24006 is allowed to partiallyself-expand by being held slightly smaller due to the configuration ofthe central lattice 24002. Likewise, an alternative of the barbellextension 24006 can allow full self-expansion when the central lattice24002 is at its self-expanded diameter. The surgeon, then, positions thebulb extension 24004 under visualization further into the LAA cavity24020 until the bulb extension 24004 seats in the LAA cavity 24020. Thesurgeon also moves the device 24000 under visualization in a yawdirection (in the plane of FIG. 240) to have the radial plane of thebarbell extension 24004 approximate and align with the plane of theatrial-appendance junction 24022. At this point, the device 24000 isstabilized within the LAA cavity 24020. Expansion of the central lattice24002 occurs when alignment is confirmed. It is noted that the expansionof the bulb extension 20404 indexes the relationship of the adjustablecentral lattice 24002 to the orifice at the atrial-appendage junction24022. As the central lattice 24002 expands, the bulb extension 24004will expand into and fill the adjacent wall of the LAA cavity 24020 toseal off the distal end of the LAA cavity 24020 from the proximal end.The central lattice 24002, again under visualization, is expanded untilthe outer surface thereof contacts the orifice at the atrial-appendagejunction 24022, at which time, the barbell extension 24006 has expandedoutward to contact as much of the atrial-appendage junction 24022 aspossible, thereby sealing the LAA cavity 24020 off from the left atrium24010. As the barbell extension 24006 is shaped to be larger in diameterthan the largest expansion diameter of the central lattice 24002, thebarbell extension 24006 will contact the wall at the atrial-appendagejunction 24022 to form a tight seal. Release of the device 24000 fromthe delivery catheter 24030 completes the operation. With such animplanted configuration, having circumferential contact at or inside theatrial-appendage junction 24022 allows endothelialization of the deviceat the LAA orifice 24022 to occur in a number of days.

Even though the device 24000 is shown without a covering in FIG. 240,some or all of the external and/or internal surfaces are covered tocreate an entirely captured volume. The device 24000 can be covered witha semiporous material to encourage ingrowth and endothelialization thatentirely fills up the LAA. Alternatively, the device 24000 can beentirely covered with non-porous material or some sections can besemiporous and some can be non-porous. By combining the barbell-shapedend shown in FIG. 234 and the bulb-shaped end shown in FIG. 235, theself-expanding and forcibly-expanding device 24000 shown in FIG. 240becomes ideal for ligating the LAA.

As mentioned above, the LAA naturally forms a curve that folds uponitself. If the LAA was pressed against the adjacent outer wall of theatrium 24012 and held there for a sufficient amount of time to seal theLAA cavity 24020 off from the left atrium 24010, the LAA would naturallyclose. However, the time for securing this result is measured in days.The self-expanding and forcibly-expanding device described herein can beused to carry out such a procedure. In particular, if the outsidesurface of the LAA and the outside surface 24012 of the atrium areaccessed by surgery, the self-expanding and forcibly-expanding devicecan be inflated against the side 24024 of the LAA opposite the atrium,thereby pressing the LAA towards the outside surface 24012 in thedirection indicated by the arrow in FIG. 240. As such, theself-expanding and forcibly-expanding device acts as a pillow thatgently and slowly presses the folded appendage closed and remains therewhile the LAA seals off by endothelialization. Due to the floppiness ofthe LAA and because of the angle that the LAA naturally forms, thedevice easily closes up the LAA orifice 24022 in this way.

Repair of a ventricular aneurysm can also be effected using the device24000. Ventricular aneurysms are one of the many complications that mayoccur after a heart attack. They usually arise from a patch of weakenedtissue in a ventricular wall, which swells into a bubble filled withblood. Such an aneurysm 24100 is shown, for example, in FIG. 241. This,in turn, may block the passageways leading out of the heart, leading toseverely constricted blood flow to the body. Ventricular aneurysms canbe fatal. Treating such aneurysms can be done by either blocking theartery supplying the aneurysm or by closing the aneursymal sac itself asan alternative to surgery. The device 24000 can be inserted into theaneursymal sac of the aneurysm 24100 and can be expanded within theaneurysm 24100 to fill and close off the aneurysm 24100.

Another vascular procedure that can be benefited by the repositionableand controlled expansion of the stent lattices of the exemplaryembodiments described herein is the area of femoral bypass surgery. Whena portion of the femoral artery becomes occluded, either partially orcompletely, one way to provide arterial blood to the portions of the legreceiving reduced blood flow is to create a shunt around the occlusion.If performed, such a shunt would require suturing of one end to alocation in the femoral artery upstream of the occlusion and suturingthe other end of the shunt to a location in the femoral arterydownstream of the occlusion. A stent graft having one of the stentlattices described herein at each of the ends of the graft material canbe utilized to create such a shunt without the need of suturing thestent graft to the femoral artery and with other benefits as describedbelow. With regard to FIG. 242 (depicting the arterial and venouscirculation of the legs), a stent graft is prepared with the graftmaterial having a length longer than the occlusion in the artery andsufficient to traverse from the upstream landing point to the downstreamlanding point in the femoral artery. A first entry point is made intothe popliteal artery and the entry catheter is led up into the femoralartery just below the occlusion. The entry catheter is, then, routed outof the femoral artery either into the saphenous vein or into thesubcutaneous fat of the thigh. In the former instance, the entrycatheter is directed up the saphenous vein and then out thereof and intothe femoral artery at a point upstream of the occlusion near the groin.In the latter instance, the entry catheter is directed through thesubcutaneous fat of the thigh along the femoral artery (withoutaccessing other vessels) and then back into the femoral artery at apoint upstream of the occlusion near the groin. With a guidewire soplaced, the delivery system of the various exemplary embodiments hereincan be guided therealong until the distal implant is located (e.g., viafluoroscopy) at the upstream implantation site. There, the stentlattice, which is surrounded by graft material (either in the lumen oroutside), is expanded to the necessary diameter (approximately between 8and 10 mm) and is checked for perivascular leak. When seated withoutexcessive outward pressure (which can be measured as described herein)and without leak, the upstream stent lattice is disconnected from thedelivery system and upstream implantation is complete. At any timeduring the upstream implantation, the stent lattice can be expanded,contracted, and re-expanded and re-positioned as desired. The deliverysheath is further retracted over the graft material and the graft lumenfills with arterial blood as this retraction occurs. Again undervisualization, the stent lattice at the downstream end of stent graft ispositioned within the femoral artery or the upper popliteal artery justdownstream of the occlusion. At any time during the downstreamimplantation, the stent lattice can be expanded, contracted, andre-expanded and re-positioned as desired until a beneficial orientationoccurs. The downstream stent lattice is expanded to the necessarydiameter and is checked for nominal pressure and no perivascular leak.When no leak is confirmed, the downstream stent lattice is disconnectedfrom the delivery system, completing the shunt and allowing arterialflow from above the occlusion to below the occlusion.

In this exemplary embodiment, the delivery system is longer thandescribed above at least by the distance between the two stent lattices.Further, one of the stent lattices is loaded into the delivery sheath atan intermediate point and the delivery sheath is extended over the graftmaterial substantially without corrugation or crumpling thereof until itreaches the upstream stent lattice. Loading of the upstream stentlattice occurs similarly as described herein and the nose cone is dockedat the distal end adjacent the upstream stent lattice. As the stentlattices (and graft) for this procedure are much smaller in diameterthan the stent lattices described for the aorta or heart, each stentlattice does not need as many expansion devices (e.g., the jackassemblies). In particular, 1, 2, or 3 of the jack assemblies are onlyneeded for stent lattices of 8 to 10 mm in installed diameter.Therefore, the actual number of lumens and drive wires needed for such asmall stent graft may be less than the ones illustrated herein, allowingfor the multilumen and delivery sheath to be made much smaller indiameter for this procedure. Accordingly, all of the control featureswill be similar as described herein but reduced in number with half ofthe control wires extending to an intermediate point within the loadeddelivery sheath to the downstream stent lattice and the other half ofthe control wires extending to the distal end of the delivery sheath tothe upstream stent lattice in a similar manner as illustrated in FIG.169.

This exemplary embodiment not only provides controllable expansion intothe fragile artery, but also eliminates the need for any suturing as thesealed upstream and downstream lattices provide the assured seal of theartery. This procedure has the added benefit of entirely eliminating anyneed for use of a balloon to inflate a stent portion, which inflationcommonly causes injury to such arterial locations.

Many of the embodiments described above for treating one or the other ofthe heart valves utilize femoral or lower aorta access to implant thereplacement stent valve. These procedures require a significantly longdelivery system.

There are a number of other surgical procedures that access valves ofthe heart with entry ports that are relatively much closer to thesurgical site. These procedures include, for example, direct opensurgery (such as sternotomy) or through port access (indirect), such asmini-sternotomy, mini-thoracotomy, thoracoscopy, or mini-thoracoscopy.In open surgery, access to the valves is very direct, as the surgeonactually touches the repair site. When sewing in a replacement valve,such as the aortic valve, fifteen or more sutures are needed, whichrequires significant prowess by the surgeon to sew in such a small area.When operating with instruments in indirect procedures, significantskill is required as well.

The inventors recognize that it is equally possible to access the valvesto be treated in these procedures with the systems, devices, and methodsdescribed herein. One advantage for doing so is because the distance tothe implantation site is so much shorter. With a short distance, controlof the handle and placement of the implant by the surgeon increases. Assuch, with this shorter device, the surgeon can deliver the prosthesisand implant it with one hand. Another significant benefit is thatcontrolled expansion of the stent lattice described entirely eliminatesall of the suturing, making the surgery easier and faster and negatingthe requirement of all surgeons to have significant technical surgicalprowess. Further, as the delivery systems described herein are verysmall in diameter, they lend themselves to use with port accesssurgeries and their concomitant benefits and faster recovery times. Withany of these shorter procedures, access from the incision site to thevalve to be replaced also is not as curved as access through the aorticarch.

Understanding the above, a variation of the systems, devices, andmethods described herein can be applied with reference to an alternativeembodiment of a delivery system described with regard to FIGS. 243 to255. FIG. 243 illustrates this alternative embodiment of a hand-helddelivery system 24300 from the side of the user, where a display surface24310 contains a display screen 24312 having all of the functions andcapabilities as described herein. Also provided are control buttons24314, 24316, and 24318 for regulating movement and deployment as setforth herein. FIGS. 244 to 250 show various views of the handle.

Internal components of the handle 24300 are visible in FIGS. 251 to 255.First, with the upper clamshell half removed, the motor and transmissionassembly 25100 are visible. This assembly 25100 contains a drive screwmotor 25102, a puck control motor 25104, and proximal and distaltransmission covers 25106, 25108. As compared to the configuration shownin FIGS. 108 to 118, many of the components are different and many areeliminated. This is because the features used to compensate forsignificant curvature are no longer needed with this short embodiment.As before six throughbores 25110 are present in the distal transmissioncover 25108 for receiving the control columns 25410 for the six drivewires 750 (not illustrated) and three throughbores 25112 are present forreceiving the puck control columns 25420 for the three puck controlscrews 17032.

FIG. 252 illustrates the exterior gears 25210 of the transmission of thepuck control motor 25104 proximal of the proximal transmission cover25106. With the distal transmission cover 25108 removed in FIG. 253, thedrive pinion 25310 and drive transmission gears 25312 for the six drivewires 750 are apparent. Also shown are the puck control gear 25320 andone puck transmission gear 25322 of the puck control screws 17032.

With the proximal transmission cover 25106 removed in FIG. 254, thedrive control columns 25410 and the puck control columns 25420 areapparent. Also shown here are the internal transmission gears 25430 forthe puck control columns 25420.

Finally, FIG. 255 shows the configuration of the puck control gear 25320driving the two exterior puck control columns 25420.

Also, as the surgeon will be physically positioning the distal end ofthe delivery system (not illustrated) at the implantation site and canmanually retract the sheath containing the stent lattice, most of theassembly for unsheathing the stent lattice is unnecessary. Present,instead, are catheter guides 25120 that retain the catheter in place. Ascompared to the previous embodiments, the delivery catheter 25130(diagrammatically shown with a dashed line) does not need to be asflexible and, therefore, is retained by the catheter guides 25120. Anexemplary embodiment of the control circuitry 25140 is shown behind thedisplay 24312.

Based upon the above, many of the distal prosthesis delivery componentsdescribed in the other exemplary embodiments are reduced in length andsome become entirely unnecessary.

An exemplary process for accessing the aortic valve is described usingthe handle 24300. It is known that access to the aortic valve can bedone in one of two ways. First, the aorta can be cross-clamped, theheart stopped, and the patient placed on bypass. The aorta is dissectedand the aortic valve is visualized directly or with a scope.Alternatively, the aorta can be accessed directly (in a preferred port)or through one of the other arteries (e.g., the sub-clavians, theinnominate, the brachial, or the axillary). The latter, being only aport access, does not require the patient to be on bypass. The latter isless invasive to the patient.

Because the delivery systems of the invention are sufficiently small tofit within a port access to the aorta, the inventive system can be usedwithout bypass. Specifically, a sheath dilator accesses one of thearteries or the aorta and provides access for a guidewire. Thisguidewire is very short and very directly reaches the aortic valve. Thesystem with the implant is run over the guidewire and visualized withinthe aortic valve. Implantation is visualized as described herein and thedevice is withdrawn by the surgeon.

When a replacement valve is to be implanted, the surgeon does not knowwith any assurance or precision the exact size of the native annulus.Presently, surgeons can determine an approximate size of the nativeannulus with fluoroscopy or with a CT scan, but both of these provideinexact results. As such, the surgeon can only guess what is the correctsize of the implant to be used and trust that the self-expanding priorart devices will seal properly and, importantly, will not embolize.

With the systems, devices, and methods of the present inventiondescribed herein, however, exact determination of the native annulussize becomes possible. More particularly, as indicated herein, theinventive stent lattice implant is inserted into the annulus in which itis to be implanted. This stent lattice does not merely expand into theannulus as prior art self-expanding devices. Instead, as describedherein, the system forcibly expands the stent lattice (e.g., thereplacement valve) into the annulus.

Each of the mechanical devices used to expand the stent lattice hasknown properties and the system, overall, can be investigated for thosecharacteristics. Some of the properties include current supplied to themotor and the torque of the motor. Because of the efficiencies of thescrews used and due to the mechanical geometry of the stent lattice, thetorque applied can be related to an outward radial force imposed by theexpanding stent lattice. Each of these characteristics can be measuredand/or calculated. Even further, the amount of torque required by themotors to open the stent lattice from at least the self-expanded stateto the fully expanded state can be measured for one stent lattice as abaseline or it can be measured for every different stent lattice to beused.

It is known that, when unloaded and in a test-bench mode, the stentlattice to be implanted will require a certain amount of torque toexpand over the entire lattice expansion range and the motors will drawa certain amount of current over that range. The required torque overthe range can be measured because, with DC motors, torque relatesproportionally to the amount of current needed by the motor to causestent lattice expansion. The current, torque, or radial force curves canbe recorded as a function of the stent lattice size and stored in amemory to define a characteristic or reference curve for that particularstent lattice. Then, during an actual (or simulated) implant, thecurrent/torque can be compared to the characteristic curve and thedeviation will indicate that there is force being applied to the tissue,which indicates first contact. From this, a process for remotelydetermining the exact size of a native annulus becomes possible. Moreparticularly, a stent lattice is installed on the delivery system and isallowed to self-expand and then is caused to expand forcibly with themotors. The characteristics of this stent lattice are recorded andstored in the memory of the delivery system as a characteristic curvefor that stent lattice. This curve is used during actual implantation(or during implantation of a simulated annulus).

Once the characteristic curve is stored for that stent lattice, theprocess for determining the native annulus can occur. The stent latticeis guided to the implantation annulus and is allowed to self-expand.Then, the system forcibly expands the stent lattice and compares thecurrent drawn to the characteristic curve. The system knows exactly thediameter of the stent lattice at each moment (based upon turns of thestent expansion control rods) and, therefore, the diameter and currentcan both be stored as a function of time. During this time, the force ofthe expanding stent lattice can be calculated and stored as a functionof time as well.

In addition to torque, current, and diameter as variables, utilizingdata processing routines and assuming a constant current, the velocityof expansion can be calculated as well and processing of these signalscan be used to detect the first substantial contact by the stent latticewithin the native annulus; this is because the expansion velocity willdecrease in a substantial way after first contact is made, at which timethe annulus begins restricting the outward expansion of the stentlattice. Depending upon the time constant for detecting, measuring, andcalculating the native annulus value based upon this first contact, thedetection could lag behind the time that the stent lattice actuallyreaches the native annulus diameter. This is not disadvantageous becausethe stent lattice needs to be implanted in the annulus, not just reachthe native diameter. Accordingly, the system can indicate (for example,on the display) the native annulus size and that additional expansion isneeded in order to complete implantation. The maximum expansion of thestent lattice along with the maximum amount of force imparted by thestent lattice upon the native annulus can be defined and the system canbe set to prevent the user from exceeding these levels duringimplantation. For example, if the native annulus is detected as being 20mm in diameter, then 24 mm can be set as the maximum size for expansion.

The system also provides implantation checks to ensure implantationforce within a predefined minimum. For example, if a minimum thresholdof implantation force is not met and the maximum diameter of the stentlattice has not been reached, then the system will not allowdisconnection to occur because there could exist a risk of latticeembolization. Conversely, if a maximum implantation force is reached butexpansion of the lattice is not within an operating range for the valveleaflets, then the system will not permit disconnection. This is becauseeven with an excellent implantation, if the leaflets will not functionappropriately, implantation should not occur.

FIGS. 261 to 263 are depictions of the simultaneous display of:

-   -   an expansion velocity v. time curve (red);    -   a force v. time curve (white); and    -   a stent lattice diameter v. time curve (green)        for a simulated native annulus of 19 mm, 20 mm, and 19.5 mm,        respectively.

In FIG. 261, expansion of the stent lattice occurs at an 18 mm diameterat about time 21:06:14. Expansion occurs at an almost constant velocityand then starts to decrease because the model begins to resist theexpansion force of the stent lattice. Then, at about 21:06:58 animplantation routine of the inventive system begins and is explainedwith the understanding that implantation of the stent lattice needs tocreate a seal at the native annulus but should not cause tissue damage.(The implantation routines for FIGS. 262 and 263 occur at about 02:34:02and 01:16:18, respectively.) The needed input variable for preventingdamage is the knowledge of the native annular diameter, which only thesystems and methods described herein can provide. With this number, thesurgeon can limit the expansion of the stent lattice and insure that itdoes not go beyond a force or size greater than pre-determined for aparticular native annulus. In particular, a method for implanting aprecision-actuated frame-based (PAF) stent (e.g., a replacement heartvalve for any of the four valves) is now described.

The stent lattice is controllably expanded at a given velocity until thesystem detects contact with and application of pressure to the nativeannulus. At this point, the system is allowed to execute an inventivesealing routine, in which force is incrementally applied to expand andrelease the stent lattice, increasing the lattice diameter just a littlebit each time. Therefore, as the tissue moves, pressure is applied but,then, the lattice is reduced somewhat for a short amount of timeallowing the tissue to relax and to remove some pressure against thetissue. Application of this expanding force to the stent lattice isrepeated to open the lattice even more but then to release it again at alarger diameter/circumference. By measuring the incremental change indiameter between each cycle, the system can determine/plot an asymptotethat will be able to detect where further force is unnecessary andimplantation is complete. Simply put, if a force is applied too rapidly,it can cause tissue to tear. By expanding the stent lattice in stagesover time, a lower installation force can achieve an implant thatcomparable to a higher instant force but without damaging the tissue ofthe annulus. This is referred to herein as “Tissue Remodeling” andoriginates from the characteristic that short-time pressure on tissueallows it to spring back quickly with no deformation but even a smallamount of pressure on tissue, if lasting a long time (e.g., a rubberband on a wrist), will leave a mark (e.g., an indentation) that willlast a while. From this it understood that there is a time constantrelating to the remodeling of the tissue because fast impartation doesnot leave a mark (high force/short time) but slow impartation (lowerforce/longer time) leaves a greater tissue remodeling “mark” or result.The time constant relates to intercellular desiccation.

After implantation, feedback parameters of the final diameter and thenative annulus are used to determine absolute and percentage changes inarea and diameter to give the surgeon information on satisfaction ofimplantation success. FIG. 264 shows what occurs on the display of FIGS.261 to 263 when detection of the native annulus is being carried out. Inthe example of FIG. 264, the native annulus is 21 mm. From the start ofthe simulated implantation process, the stent lattice is reduced in sizefrom just over 24 mm. Throughout the process, the green curve in themiddle window is displayed. The green curve is the characteristic curveof the particular stent lattice being implanted, which was definedoff-line before this implantation example. The characteristic curve isstored in memory of the system and is plotted as a function of the stentlattice diameter.

As can be seen in the four stages of reduction (starting at about15:14:10), the velocity of reduction (shown in the bottom window in red)is substantially constant after reduction start-up. The diameter curve(yellow) shows the stent lattice being contracted down to about 18.5 mm.The stent lattice is advanced and placed in the annulus for implantationwhile in this contracted state. Expansion starts at approximately15:14:45. It is noted that, as the stent lattice is contracting andexpanding, the actual force (blue) applied to the stent lattice (whichis related to torque/current) is plotted against the characteristiccurve, which correlation can be seen from about 15:14:10 to about15:14:43. When implantation is occurring, the force curve (blue) tracksthe characteristic curve (green) until about 15:14:50, at which time,the force curve deviates from the characteristic curve. It is at thispoint where the native annulus of 21 mm is reach and is detected by thatdeviation.

While utilization of this deviation to determine native annulus size isthe first time such a measurement could be taken with reliability andaccuracy and without injury to the anatomy, it is known that thestructure of the implantation site is pliable and, therefore, the nativeannulus determined in this manner (without more) could be slightlylarger than the actual annulus size. Further, the time delay betweenexpansion and measurement, while small, does impart a lag in the annulusdetection conclusion. To improve upon this measurement, various signalprocessing routines can be implemented using the parameters beingmeasured by the system. For example, improvement of the measurement canoccur in the following manner. First, the stent lattice can be expandedthroughout its range prior to use to define a force v. diametercharacteristic curve for that lattice. Then, the force v. diameter curvecan be measured dynamically during implantation in the native annulus.While this is occurring, the two curves can be compared. When the nativeannulus is detected, that time point on the force v. diameter curve canbe stored and a tangent line can be determined. This tangent line willproject backward in time and will intersect the stored force v. diametercharacteristic curve at a point smaller in diameter than the detectednative annulus. It is this smaller diameter point where the tangent lineintersects that can be considered to be a “true” native annulus (beforeany force is imparted on the native annulus to give a larger than “true”determination). As indicated, many signal processing routines can beused now that measurements from the device both on a test-bed anddynamically during an implantation can be obtained with the systems andmethods described.

It is useful to have a single characteristic curve for every stentlattice. However, every stent lattice and delivery system is differenton a micro-scale. Nonetheless, the systems and methods described can beused to determine a “single” characteristic curve of similar stentlattices based upon averages of measured curves, for example. But, ifextreme accuracy is desired, every time a stent lattice is mated to adelivery device, the particular characteristic curve can be created onthe fly for that particular implant and can be stored in the memory ofthat delivery system for use during implantation of that implant.

The systems shown in FIGS. 169 to 180 and 191 illustrate exemplaryembodiments of connectivity between the drive-screw proximal ends of thestent lattice and the control subassemblies including the drive screwsand the disconnect wires. If the distance between these two points istoo small, then, even though the connections are coils and flexiblewires, the wires will not bend easily as the system is guided aroundcurved vessels. In contrast, if the distance is very long, then theflexible coils and wires will be very flexible and might not have enoughcolumnar strength to push through curved vessels. Therefore, thisdistance is set (along with selection of the material properties of thedisconnect coils and drive wires) to allow the stent to be extended outand retracted back within a curved anatomy while still having enoughcolumnar strength to not buckle when pushed distally.

Even with these properties balanced and with excellent tracking throughcurved vessels, the length of each of the coil/wire subassembliesremains the same. This means that, when traversing through a curve, someof the lengths will be allowed to remain taut and some will shorten(i.e., the inside wires will be in compression and the outside wireswill be in tension). Thus, the flexible coil/wire subassemblies willoppose any curving that axially aligns the cylinder of the expandedstent lattice with the cylinder of the curved anatomy in which the stentlattice is currently placed. The result is that the stent lattice isforced into an angled position in the native annulus that is not ideal.

One way to correct for this angled position is through activeswashplating, for example, utilizing the exemplary systems illustratedin FIGS. 89 to 103. As can be seen in the progression of FIGS. 265 to268, active swashplating of the subassemblies allows the partiallyexpanded stent lattice in FIG. 265 to be rotated counter-clockwise withregard to the view of the figure (FIG. 266), to be rotated clockwise(FIG. 267), and to be implanted (FIG. 268).

Without active swashplating, for implantation of a replacement aorticvalve, there will be a difference in the distance from the distal groundon the delivery sheath to each of the connection points (e.g., six) onthe replacement valve's stent lattice as the delivery device is flexedaround the aortic arch. This difference in path length is a function ofthe difference in diameter of the arch that each of the connectionpoints pass through. The path is shorter for the inside coils/wires andlonger for those on the outside of the arch. Where all of the controlcoils/wires are the same length, the similar lengths will cause anangled orientation.

To overcome this difference in alignment, an exemplary angularcorrection device 26810 is shown in FIG. 269 with the disconnectioncoils 26920 and the screw wires 26930 lengthened to be even moreflexible than in the above embodiments. As such, the coil/wiresubassemblies are free to move into an orientation that does not impartthis angling force on the stent lattice. The angular correction device26910 is grounded at the connector control sub-assembly 17000 and has aband 26912 extending distally at least until the proximal end of thestent lattice. The band 26912 has guide sleeves 26814 that laterallyhold one of the coil/wire subassembly 26920/26930 therein so that thisone subassembly follows the band 26912. In an exemplary embodiment, theband 26912 has guidewire sleeves 26916 on the side opposing the onesubassembly to laterally hold the guidewire sleeve 26940 thereto.

With the angular correction device 26810, the subassembly 26920/26930held to the band 26912 will follow the superior axis of the aortic archas shown in FIG. 270, and, thereby, will cause the stent lattice to dothe same. The flex of the band forces the band to the greater curvatureof the arch and holds and supports the stent lattice in a position thatis tangent to the end of the arch curve. This, in turn, places thelateral wall of the stent lattice on the superior side against theimplantation site substantially aligned with (parallel to) the superiorarch of the implantation site, which is a desirable implantationposition for the stent lattice. As a result, the stent lattice isautomatically placed coaxial to the axis on the native annulus, which issignificant because coaxiality is the most desired orientation forlimiting the depth into the left ventricular outflow tract and isrequired for lining up the sealing zone of the implant with the sealingarea of the native annulus. An angular misalignment here can cause leaksor poor valve function. It can also contribute to lower gradients ornegative impact on the hearts conduction system.

The band 26912 provides additional benefits: it supports the stent fromrotating and gives the user an ability to apply longitudinal forces forprecise positioning. Further, if the band 26912 is provided with forksor tines that engage the proximal end of the stent lattice, these tinescan be used to rotate or translate the stent lattice as an additionalmeasure for stent lattice repositioning.

With a parallel implantation orientation, expansion of the stent lattice(shown in FIG. 271, will cause an implantation that is virtuallyparallel to the implantation site. An added benefit to thisconfiguration is that the band 26912 (along with the delivery sheath)can be pulled proximally away from the implantation site, as shown inFIG. 272, to rotate the plane of the stent lattice (here clockwise inthe figure) to accommodate differing anatomy or for any other reasondesired by the surgeon.

Because only one of the subassemblies is connected to the band 26912,the other loose and flexible wires are free to reposition themselveswithin the arch and find a natural path that allows parallelimplantation within the vessel, which paths are illustrated in FIG. 271.

An exemplary embodiment of the band 26912 is a stainless steel stripthat is much wider (e.g., between approximately 0.050 inches andapproximately 0.2 inches) than it is thick (e.g., between approximately0.005 inches and approximately 0.02 inches).

When the band 26912 presses the stent lattice in the implantation site,the orientation of the lateral wall of the stent lattice with respect tothe implantation site will most likely be rotated too much in theclockwise direction of FIGS. 270 to 272. In order to accommodate forthis possibility, in an alternative and/or additional exemplaryembodiment, the band 26912 can be provided with a pre-bend just proximalof the stent lattice. In such a configuration, the stent lattice will berotated slightly counter-clockwise in the view of these figures. Anotherexemplary embodiment provides an active hinge at the distal end of theband 26912 just before the proximal end of the stent lattice and havinga control rod that extends back towards the delivery handle. Whenactuated in the proximal direction, the end of the band will rotatecounter-clockwise and, thereby, move the stent lattice similarly.

It is noted that various individual features of the inventive processesand systems may be described only in one exemplary embodiment herein.The particular choice for description herein with regard to a singleexemplary embodiment is not to be taken as a limitation that theparticular feature is only applicable to the embodiment in which it isdescribed. All features described herein are equally applicable to,additive, or interchangeable with any or all of the other exemplaryembodiments described herein and in any combination or grouping orarrangement. In particular, use of a single reference numeral herein toillustrate, define, or describe a particular feature does not mean thatthe feature cannot be associated or equated to another feature inanother drawing figure or description. Further, where two or morereference numerals are used in the figures or in the drawings, thisshould not be construed as being limited to only those embodiments orfeatures, they are equally applicable to similar features or not areference numeral is used or another reference numeral is omitted.

The foregoing description and accompanying drawings illustrate theprinciples, exemplary embodiments, and modes of operation of theinvention. However, the invention should not be construed as beinglimited to the particular embodiments discussed above. Additionalvariations of the embodiments discussed above will be appreciated bythose skilled in the art and the above-described embodiments should beregarded as illustrative rather than restrictive. Accordingly, it shouldbe appreciated that variations to those embodiments can be made by thoseskilled in the art without departing from the scope of the invention asdefined by the following claims.

What is claimed is:
 1. A method for implanting a stent, which comprises:contracting a stent to a reduced implantation size with a deliverysystem having drive wires, the stent having a selectively adjustableassembly with adjustable elements operatively connected to the drivewires such that, when the adjustable elements are adjusted by the drivewires, a configuration change in at least a portion of the stent occurs;inserting the contracted stent into a native annulus in which the stentis to be implanted; rotating the drive wires with the delivery system toforcibly expand the stent; while rotating the drive wires, determiningwith the delivery system a torque applied to the drive wires; stoppingrotation of the drive wires based upon a value of the determined torquewhen the stent contacts the native annulus and has a first diameter; andafter the stent contacts the native annulus, repeatedly rotating andstopping rotation of the drive wires to incrementally expand the stentfrom the first diameter to a second, final diameter.
 2. The methodaccording to claim 1, which further comprises providing a user with adynamic value of the torque and permitting the user to change theexpansion and contraction of the stent.
 3. The method according to claim2, which further comprises disconnecting the stent from the deliverysystem to implant the stent in the native annulus.
 4. The methodaccording to claim 1, which further comprises disconnecting the stentfrom the delivery system to implant the stent in the native annulus. 5.The method according to claim 1, wherein the delivery system has atleast one drive wire motor connected to the drive wires for rotating thedrive wires and wherein the act of stopping includes: measuring acurrent required to drive the at least one drive wire motor; andstopping the at least one drive wire motor and thereby the rotation ofthe drive wires based upon a value of the current.
 6. The methodaccording to claim 5, which further comprises: calculating an outwardradial force imposed by the expanding stent lattice on the nativeannulus with the value of the current; and stopping the at least onedrive wire motor and thereby the rotation of the drive wires based upona value of the calculated outward radial force.
 7. The method accordingto claim 1, wherein the delivery system has at least one drive wiremotor connected to the drive wires for rotating the drive wires andwherein the act of stopping includes: determining an outward radialforce imposed by the expanding stent lattice based upon a currentrequired to drive the at least one drive wire motor; and stopping the atleast one drive wire motor and thereby the rotation of the drive wiresbased upon a value of the calculated outward radial force.
 8. The methodaccording to claim 1, wherein stopping the rotation of the drive wiresas the stent incrementally expands from the first diameter to the seconddiameter allows the stent to contract to a plurality of intermediatediameters between the first diameter and the second diameter due toforce of the native annulus pressing against the stent.
 9. The methodaccording to claim 1, wherein repeatedly rotating and stopping rotationof the drive wires includes: rotating the drive wires such that thestent expands from the first diameter to a third diameter which is lessthan the second diameter; and stopping rotation of the drive wires afterthe stent has the third diameter, whereupon the stent contracts from thethird diameter to a fourth diameter which is less than the seconddiameter and the third diameter and greater than the first diameter dueto force of the native annulus pressing against the stent.
 10. Themethod according to claim 9, wherein repeatedly rotating and stoppingrotation of the drive wires includes: rotating the drive wires such thatthe stent expands from the fourth diameter to a fifth diameter which isless than the second diameter and greater than the third diameter; andstopping rotation of the drive wires after the stent has the fifthdiameter, whereupon the stent contracts from the fifth diameter to asixth diameter which is less than the second diameter and the fifthdiameter and greater than the fourth diameter due to force of the nativeannulus pressing against the stent.
 11. A method for implanting a stent,which comprises: contracting a stent to a reduced implantation size witha delivery system having drive wires, the stent having a selectivelyadjustable assembly with adjustable elements operatively connected tothe drive wires such that, when the adjustable elements are adjusted bythe drive wires, a configuration change in at least a portion of thestent occurs; inserting the contracted stent into a native annulus inwhich the stent is to be implanted; rotating the drive wires with thedelivery system to forcibly expand the stent; while rotating the drivewires, determining with the delivery system a torque applied to thedrive wires; stopping rotation of the drive wires based upon a firstvalue of the determined torque when the stent contacts the nativeannulus; and repeatedly rotating and stopping rotation of the drivewires based upon a second of value of the determined torque greater thanthe first value to incrementally expand the stent after the stentinitially contacts the native annulus.
 12. The method according to claim11, which further comprises providing a user with a dynamic value of thetorque and permitting the user to change the expansion and contractionof the stent.
 13. The method according to claim 12, which furthercomprises disconnecting the stent from the delivery system to implantthe stent in the native annulus.
 14. The method according to claim 11,which further comprises disconnecting the stent from the delivery systemto implant the stent in the native annulus.
 15. The method according toclaim 11, wherein the delivery system has at least one drive wire motorconnected to the drive wires for rotating the drive wires and whereinthe act of stopping includes: measuring a current required to drive theat least one drive wire motor; and stopping the at least one drive wiremotor and thereby the rotation of the drive wires based upon a value ofthe current.
 16. The method according to claim 15, which furthercomprises: calculating an outward radial force imposed by the expandingstent lattice on the native annulus with the value of the current; andstopping the at least one drive wire motor and thereby the rotation ofthe drive wires based upon a value of the calculated outward radialforce.
 17. The method according to claim 11, wherein the delivery systemhas at least one drive wire motor connected to the drive wires forrotating the drive wires, and wherein the act of stopping includes:determining an outward radial force imposed by the expanding stentlattice based upon a current required to drive the at least one drivewire motor; and stopping the at least one drive wire motor and therebythe rotation of the drive wires based upon a value of the calculatedoutward radial force.
 18. A method for implanting a stent, whichcomprises: contracting a stent to a reduced implantation size with adelivery system having drive wires, the stent having a selectivelyadjustable assembly with adjustable elements operatively connected tothe drive wires such that, when the adjustable elements are adjusted bythe drive wires, a configuration change in at least a portion of thestent occurs; inserting the contracted stent into a native annulus inwhich the stent is to be implanted; moving the drive wires with thedelivery system to forcibly expand the stent; while moving the drivewires, determining with the delivery system a torque applied to thedrive wires; and temporarily stopping movement of the drive wires basedupon a first value of the determined torque when the stent contacts thenative annulus; and after the stent contacts the native annulus,repeatedly moving and stopping the drive wires based upon a second valueof the determined torque greater than the first value to incrementallyexpand the stent.
 19. The method according to claim 18, wherein the actof moving comprises rotating the drive wires to forcibly expand thestent into the native annulus.
 20. The method according to claim 18,which further comprises providing a user with a dynamic value of thetorque and permitting the user to change the expansion and contractionof the stent.
 21. The method according to claim 20, which furthercomprises disconnecting the stent from the delivery system to implantthe stent in the native annulus.
 22. The method according to claim 18,which further comprises disconnecting the stent from the delivery systemto implant the stent in the native annulus.
 23. The method according toclaim 18, wherein the delivery system has at least one drive wire motorconnected to the drive wires for rotating the drive wires and whereinthe act of stopping includes: measuring a current required to drive theat least one drive wire motor; and stopping the at least one drive wiremotor and thereby the rotation of the drive wires based upon a value ofthe current.
 24. The method according to claim 23, which furthercomprises: calculating an outward radial force imposed by the expandingstent lattice on the native annulus with the value of the current; andstopping the at least one drive wire motor and thereby the rotation ofthe drive wires based upon a value of the calculated outward radialforce.
 25. The method according to claim 18, wherein the delivery systemhas at least one drive wire motor connected to the drive wires forrotating the drive wires and wherein the act of stopping includes:determining an outward radial force imposed by the expanding stentlattice based upon a current required to drive the at least one drivewire motor; and stopping the at least one drive wire motor and therebythe rotation of the drive wires based upon a value of the calculatedoutward radial force.